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Impoyz clobetasol propionate .25 mg/g Cream — NDC 68040-0713-38 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Impoyz clobetasol propionate .25 mg/g Cream — NDC 68040-713-38 (Billing 68040-0713-38)

by Primus Pharmaceuticals, Inc. · 1 TUBE in 1 CARTON / 100 g in 1 TUBE

This is a package of Impoyz clobetasol propionate .25 mg/g Cream from Primus Pharmaceuticals, Inc., marketed since Dec 2021 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 68040-0713-38
🏷️ FDA NDC (as labeled) 68040-713-38 billing pads the product segment with a zero
This package
Contains100 g in 1 tube Pack sizes2 compare ↓
Main listing for product 68040-713 · Also comes in: 20 tubes 68040-713-44
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68040-713-38 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68040 labeler · 713 product · 38 package
Package marketed since
Dec 1, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6804071338 1
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 3, 2026 — Failed content uniformity specifications. (Lupin Pharmaceuticals Inc.) · FDA recall D-0789-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68040-713-38
Product NDC 68040-713
11-digit billing NDC 68040071338
NCPDP billing unit GM — per gram (weight)
RxCUI 1995455, 1995460
UNII 779619577M
Application # NDA209483
SPL Set ID 40173654-334e-4618-847b-6a1e030cd2fd
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-12-01
Route TOPICAL
Dosage form CREAM
Substance CLOBETASOL PROPIONATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90550025103703
GPI class Impoyz
GCN Seq No 077979
GCN 44155
HICL code 003327
Ingredient (HICL) Clobetasol Propionate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5P
Therapeutic class — specific (HIC3) Topical Anti-Inflammatory Steroidal
AHFS code 84:06.08.00
AHFS class Corticosteroids (Skin, Mucous Membrane)
FDB label name IMPOYZ 0.025% CREAM
FDB brand name Impoyz
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 077979
  • GCN: 44155
  • GPI-14 (Medi-Span): 90550025103703
  • HICL (First Databank): 003327
  • AHFS class code: 84:06.08.00
  • RxCUI (RxNorm): 1995455
Why two NDCs? The FDA registers this code as 68040-713-38 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68040-0713-38. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, very potent (group IV), Corticosteroids, plain
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name IMPOYZ 0.025% CREAM Ingredient Clobetasol Propionate
📖 What it is MedlinePlus · NLM

Clobetasol topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various scalp and skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body) and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Clobetasol is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Clobetasol propionate shampoo is for moderate to severe scalp psoriasis in adults 18 and older. It is not for use on your face, groin or underarms.
  • Apply a thin film to dry, affected scalp areas once a day. Leave it on for 15 minutes, then lather and rinse well. Wash your hands afterward and keep it away from your eyes and lip...
  • No more than 4 consecutive weeks, and stop sooner if your psoriasis is controlled. If you are not better in 4 weeks, check in with your doctor.
  • Burning, stinging, itching, dryness and acne-like bumps are the most common. Call your doctor if irritation is severe, you see signs of infection, or you notice eye pain or blurred...
📖 Read our full Clobetasol Topical guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Clobetasol Propionate — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Clobetasol Propionate (3 interactions) — ranked by severity →
8
Nutrient depletion considerations

Clobetasol may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Clobetasol nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 20 tubes
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68040-0713-38 You're viewing this Main listing 1 TUBE in 1 CARTON / 100 g in 1 TUBE 2021-12-01 — Active
68040-0713-44 68040-713-44 20 TUBE in 1 CARTON / 2.5 g in 1 TUBE 2021-12-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 100 g in 1 tube.
What NDC number is used to bill for this package of Impoyz clobetasol propionate .25 mg/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Impoyz .25 mg/gthis 68040-0713-38 Primus 1 tube — — FDA listed —
Clobetasol Propionate .25 mg/g 74157-0710-10 INA 1 tube — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2017
First FDA approval
Nov 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 28, 2017 RLD RS ⏳ ~8.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10064875 — method of use (U-88)
US 10064875 — method of use (U-1858)
US 9956231 — method of use (U-88)
US 10064875 — method of use (U-193)
US 10064875 — method of use (U-1408)
US 9956231 — method of use (U-1408)
US 9956231 — method of use (U-193)
US 9956231 — method of use (U-742)
US 9956231 — method of use (U-1858)
US 10064875 — method of use (U-742)
US 11179465 — method of use (U-1858)
US 10588914 — method of use (U-2771)
US 9956231 — method of use (U-1761)
US 9855334 — drug product
2017 2019 2021 2023 2025 2027 2029 2031 2033 2035
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (14)
PatentTypeUse codeExpires
US 10064875 ↗ Method of use U-88 Aug 31, 2030
US 10064875 ↗ Method of use U-1858 Aug 31, 2030
US 9956231 ↗ Method of use U-88 Aug 31, 2030
US 10064875 ↗ Method of use U-193 Aug 31, 2030
US 10064875 ↗ Method of use U-1408 Aug 31, 2030
US 9956231 ↗ Method of use U-1408 Aug 31, 2030
US 9956231 ↗ Method of use U-193 Aug 31, 2030
US 9956231 ↗ Method of use U-742 Aug 31, 2030
US 9956231 ↗ Method of use U-1858 Aug 31, 2030
US 10064875 ↗ Method of use U-742 Aug 31, 2030
US 11179465 ↗ Method of use U-1858 Aug 31, 2030
US 10588914 ↗ Method of use U-2771 Aug 31, 2030
US 9956231 ↗ Method of use U-1761 Aug 31, 2030
US 9855334 ↗ Drug product — Mar 11, 2035
Common questions
Is there a generic version of IMPOYZ 0.025% CREAM?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for IMPOYZ 0.025% CREAM. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Clobetasol Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII NMQ347994Z
    Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
  • UNII A1A1I8X02B
    A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
  • UNII FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPrimus Pharmaceuticals, Inc.
Application holderPRIMUS PHARMACEUTICALS INC
FDA applicationNDA209483 (NDA)
Labeler code68040
First marketedDec 2021
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Primus Pharmaceuticals, Inc. labeler code 68040

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 52 words ▾

1 INDICATIONS AND USAGE IMPOYZ Cream 0.025% is indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age and older. IMPOYZ Cream is a corticosteroid indicated for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Apply a thin layer of IMPOYZ Cream to the affected skin areas twice daily and rub in gently and completely. Use IMPOYZ Cream for up to 2 consecutive weeks of treatment. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic pituitary adrenal (HPA) axis [see Warnings and Precautions (5.1) ].

Discontinue IMPOYZ Cream when control is achieved. Do not use if atrophy is present at the treatment site. Do not bandage, cover, or wrap the treated skin area unless directed by a physician.

Avoid use on the face, scalp, axilla, groin, or other intertriginous areas. IMPOYZ Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Wash hands after each application. Apply a thin layer of IMPOYZ Cream to the affected skin areas twice daily and rub in gently and completely. Wash hands after each application.

Use IMPOYZ Cream for up to 2 consecutive weeks of treatment. ( 2 ) Discontinue IMPOYZ Cream when control is achieved. ( 2 ) The total dosage should not exceed 50 g per week.

( 2 ) Do not use if atrophy is present at the treatment site. ( 2 ) Do not bandage, cover, or wrap the treated skin areas unless directed by a physician. ( 2 ) Avoid use on the face scalp, axilla, groin, or other intertriginous areas.

( 2 ) IMPOYZ Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use. ( 2 )

💊 Dosage Forms and Strengths 27 words ▾

3 DOSAGE FORMS AND STRENGTHS Cream, 0.025% each gram contains 0.25 mg of clobetasol propionate in a white to off-white cream base. Cream, 0.025% ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Clobetasol propionate has been shown to suppress the HPA axis at the dose tested. ( 5.1 ) Cushing’s syndrome, hyperglycemia, and glucosuria can also result from systemic absorption of topical corticosteroids. ( 5.1 ) Systemic absorption may require periodic evaluation for HPA axis suppression.

Modify use if HPA axis develops. ( 5.1 ) Children may be more susceptible to systemic toxicity from use of topical corticosteroids. ( 5.1 , 8.4 ) Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings, prolonged use, or use of higher potency corticosteroids, including clobetasol propionate.

These reactions include; irritation, dryness, acneiform eruptions, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. ( 5.1 , 6.2 )

5.1Effects on the Endocrine System IMPOYZ Cream can cause reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Because of the potential of systemic absorption, use of topical corticosteroids, including IMPOYZ Cream, may require that patients be evaluated periodically for evidence of HPA axis suppression.

Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of IMPOYZ Cream on the HPA axis, subjects with plaque psoriasis applied IMPOYZ Cream twice daily to at least 20% of involved Body Surface Area (BSA) for 15 days.

Abnormal ACTH stimulation tests suggestive of HPA axis suppression were seen in 3 of 24 (12.5%) subjects on IMPOYZ Cream [see Clinical Pharmacology (12.2) ]. In another trial to evaluate the effects of IMPOYZ Cream on the HPA axis, subjects with moderate to severe plaque psoriasis applied IMPOYZ Cream twice daily to at least 25% of involved BSA for 28 consecutive days. Abnormal ACTH stimulation test suggestive of HPA axis suppression was seen in 8 of 26 (30.8%) of subjects on IMPOYZ Cream.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These complications are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.

Minimize the unwanted risks from endocrine effects by mitigating risk factors favoring increased systemic bioavailability and by using the product as recommended [see Dosage and Administration (2) ]. Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios [see Use in Specific Populations (8.4) ].

5.2Local Adverse Reactions with Topical Corticosteroids Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including IMPOYZ Cream. Some local adverse re… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The most common adverse reaction (incidence ≥ 1%) is application site discoloration. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Primus Pharmaceuticals Inc. at 480-483-1410 or FDA at 1-800-FDA-1088 or www. FDA.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. IMPOYZ Cream was evaluated in two randomized, multicenter, prospective, vehicle-controlled clinical trials in subjects with moderate to severe plaque psoriasis. Subjects applied IMPOYZ Cream or vehicle cream twice daily for 14 days.

A total of 354 subjects applied IMPOYZ Cream and 178 subjects applied vehicle. The adverse reaction that occurred in at least 1% of subjects treated with IMPOYZ Cream and at a higher incidence than in subjects treated with vehicle cream was application site discoloration (2% versus 1%). Less common local adverse events occurring in < 1% of subjects treated with IMPOYZ Cream were application site atrophy, telangiectasia and rash.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of clobetasol propionate: striae, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis and miliaria. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on IMPOYZ Cream in pregnant women to inform a drug-associated risk for adverse development outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroids during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use IMPOYZ Cream on the smallest area of skin and for the shortest duration possible (see Data ).

In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparisons of animal exposure with human exposure are provided due to minimal systemic exposure noted after topical administration of IMPOYZ Cream [see Clinical Pharmacology (12.3) ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk or birth defect loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality.

However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants [adjusted RR, 7.74 (95% CI, 1.49-40.11)]. In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body [a mean quantity of 60 g/month (range, 12-170g)] over long periods of time.

Animal Data In an embryofetal development study in mice, subcutaneous administration of clobetasol propionate resulted in fetotoxicity at the highest dose tested ( 1mg/kg) and malformations at the lowest dose tested (0.03 mg/kg). Malformations seen included cleft palate and skeletal abnormalities. In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg.

Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities.

8.2Lactation Risk Summary There is no information regarding the presence of clobetasol propionate in breast milk or its effects on the breastfed infant or on milk production. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of clobetasol propionate could result in sufficient systemic absorption to produce detectable quantities in human milk.

The developmental and health benefits of breastfeeding should be considered along with the other’s clinical need for IMPOYZ Cream and any potential adverse effects on the breastfed infant from IMPOYZ Cream or from the underlying maternal condition. Clinical Considerations To minimize potential exposure to the breastfed infant via breast milk, use IMPOYZ Cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply IMPOYZ Cream directly to the nipple and areola to avoid direct infant exposure.

8.4Pediatric Use The safety and effectiveness of IMPOYZ Cream in patients younger than 18 years of age have not been established; therefore, use in children younger than 18 years is not recommended. Because of a hig… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available data on IMPOYZ Cream in pregnant women to inform a drug-associated risk for adverse development outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroids during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use IMPOYZ Cream on the smallest area of skin and for the shortest duration possible (see Data ).

In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparisons of animal exposure with human exposure are provided due to minimal systemic exposure noted after topical administration of IMPOYZ Cream [see Clinical Pharmacology (12.3) ]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk or birth defect loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Multiple observational studies found no significant associations between maternal use of topical corticosteroids of any potency and congenital malformations, preterm delivery, or fetal mortality.

However, when the dispensed amount of potent or very potent topical corticosteroid exceeded 300 g during the entire pregnancy, use was associated with an increase in low birth weight infants [adjusted RR, 7.74 (95% CI, 1.49-40.11)]. In addition, a small cohort study, in which 28 sub-Saharan women using potent topical corticosteroids (27/28 used clobetasol propionate 0.05%) for skin lightening during pregnancy, noted a higher incidence of low birth weight infants in the exposed group. The majority of exposed subjects treated large areas of the body [a mean quantity of 60 g/month (range, 12-170g)] over long periods of time.

Animal Data In an embryofetal development study in mice, subcutaneous administration of clobetasol propionate resulted in fetotoxicity at the highest dose tested ( 1mg/kg) and malformations at the lowest dose tested (0.03 mg/kg). Malformations seen included cleft palate and skeletal abnormalities. In an embryofetal development study in rabbits, subcutaneous administration of clobetasol propionate resulted in malformations at doses of 0.003 and 0.01 mg/kg.

Malformations seen included cleft palate, cranioschisis, and other skeletal abnormalities.

🧒 Pediatric Use 138 words ▾

8.4Pediatric Use The safety and effectiveness of IMPOYZ Cream in patients younger than 18 years of age have not been established; therefore, use in children younger than 18 years is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity, including HPA axis suppression when treated with topical drugs [see Warnings and Precautions (5.1) ]. Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

Local adverse reactions including striae and skin atrophy have also been reported with use of topical corticosteroids in pediatric patients. Avoid use of IMPOYZ Cream in the treatment of diaper dermatitis.

🧓 Geriatric Use 47 words ▾

8.5Geriatric Use Clinical studies of IMPOYZ Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with topical corticosteroids has not identified differences in responses between the elderly and younger patients.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid responsive dermatoses is unknown. The contribution to efficacy by individual components of the vehicle has not been established.

12.2Pharmacodynamics Vasoconstrictor Assay IMPOYZ Cream, 0.025% is in the high range of potency as demonstrated in vasoconstrictor studies in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: HPA axis suppression was evaluated in a clinical trial in adult subjects (N=24) with moderate to severe plaque psoriasis involving a mean BSA of 26.5 +8.6%.

Treatment consisted of twice daily application of IMPOYZ Cream, 0.025% for 15 days. Adrenal suppression, as indicated by a 30-minute post-stimulation cortisol level ≤18 mcg/dL, was observed in 3 out of 24 subjects (12.5%) after 15 days.

12.3Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation, and/or other disease processes in the skin may also increase percutaneous absorption.

Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile. In a pharmacokinetic study in 24 adult male and female subjects with moderate to severe psoriasis were treated twice daily for 15 days with a mean dose of approximately 3.7 g of IMPOYZ Cream, 0.025% per application to a mean BSA of 26.5 ± 8.6%.

On day 15, the mean + SD pre-treatment and post-treatment systemic concentrations of clobetasol propionate were 50.7 ± 96.0 pg/mL and 56.3 ± 104.7 pg/mL, respectively.

🧬 Mechanism of Action 63 words ▾

12.1Mechanism of Action Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid responsive dermatoses is unknown. The contribution to efficacy by individual components of the vehicle has not been established.

16.1How Supplied IMPOYZ Cream, 0.025% is a white off-white cream, supplied as follows: 100 g aluminum tube NDC 68040-713-38

📦 How Supplied / Storage and Handling 44 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied IMPOYZ Cream, 0.025% is a white off-white cream, supplied as follows: 100 g aluminum tube NDC 68040-713-38

16.2Storage Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Do not freeze.

📦 Storage and Handling 19 words ▾

16.2Storage Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Do not freeze.

📋 Description 116 words ▾

11 DESCRIPTION IMPOYZ (clobetasol propionate) Cream, 0.025% for topical use contains clobetasol propionate, a synthetic and fluorinated corticosteroid. Chemically, clobetasol propionate is 21-chloro-9-fluoro-11β-hydroxy-16 β-methyl-3,20-dioxopregna-1,4-dien-17-yl propanoate, and it has the following structural formula. Clobetasol propionate has a molecular formula of C 25 H 32 CIFO 5 and a molecular weight of 467.

It is a white to cream-colored crystalline powder practically insoluble in water. Each gram of IMPOYZ Cream contains 0.25 mg clobetasol propionate. It is an oil-in-water emulsion intended for topical application and contains the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, cyclomethicone, diethylene glycol monoethyl ether, glyceryl stearate and PEG 100 stearate, isopropyl myristate, methyl paraben, propyl paraben. purified water and white wax.

Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information ) Pregnancy Advise pregnant women of the potential risk to a fetus and to use IMPOYZ Cream on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1) ] . Lactation Advise a woman to use IMPOYZ cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply IMPOYZ Cream directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2) ] .

Important Administration Instructions Instruct patients to discontinue IMPOYZ Cream when psoriasis is controlled. IMPOYZ Cream should not be used for longer than 2 weeks. Advise patients to contact the physician if no improvement is seen within 2 weeks.

Inform patients that total dosage should not exceed 50 grams per week [see Dosage and Administration (2) ]. Instruct patients to avoid bandaging, wrapping or otherwise occluding the treatment area(s) unless directed by physician. Advise patients to avoid use on the face, scalp, groin, or axillae [see Dosage and Administration (2) ].

Inform patients that IMPOYZ Cream is for external use only. Advise patients that IMPOYZ Cream is not for ophthalmic, oral or intravaginal use. Patients should wash their hands after applying the medication [see Dosage and Administration (2) ] .

Do not use other corticosteroid-containing products while using IMPOYZ Cream. Effects on Endocrine System IMPOYZ Cream may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including IMPOYZ Cream, may require periodic evaluation for HPA axis suppression.

Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids. Patients should inform their physician(s) that they are using IMPOYZ Cream if surgery is contemplated [see Warnings and Precautions (5.1) ] .

Local Adverse Reactions Informed patients that topical corticosteroids may cause local adverse reactions, some of which may be irreversible. These reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids, including IMPOYZ Cream [see Warnings and Precautions (5.2) ] . Patients should report any sign of local or systemic adverse reactions to their physician.

Manufactured by DPT Laboratories Ltd. San Antonio, TX 78215 For Primus Pharmaceuticals, Inc., Scottsdale AZ 85253 IMPOYZ is a registered trademark of Primus Pharmaceuticals, Inc. www.primusrx.com Revised: 04/2021

🧬 Pharmacokinetics 151 words ▾

12.3Pharmacokinetics Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation, and/or other disease processes in the skin may also increase percutaneous absorption.

Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile. In a pharmacokinetic study in 24 adult male and female subjects with moderate to severe psoriasis were treated twice daily for 15 days with a mean dose of approximately 3.7 g of IMPOYZ Cream, 0.025% per application to a mean BSA of 26.5 ± 8.6%.

On day 15, the mean + SD pre-treatment and post-treatment systemic concentrations of clobetasol propionate were 50.7 ± 96.0 pg/mL and 56.3 ± 104.7 pg/mL, respectively.

🧬 Pharmacodynamics 105 words ▾

12.2Pharmacodynamics Vasoconstrictor Assay IMPOYZ Cream, 0.025% is in the high range of potency as demonstrated in vasoconstrictor studies in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence. Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression: HPA axis suppression was evaluated in a clinical trial in adult subjects (N=24) with moderate to severe plaque psoriasis involving a mean BSA of 26.5 +8.6%.

Treatment consisted of twice daily application of IMPOYZ Cream, 0.025% for 15 days. Adrenal suppression, as indicated by a 30-minute post-stimulation cortisol level ≤18 mcg/dL, was observed in 3 out of 24 subjects (12.5%) after 15 days.

🔬 Clinical Studies 167 words ▾

14 CLINICAL STUDIES Two double-blind, randomized, vehicle-controlled trials evaluated 532 subjects aged 18 years and older with moderate to severe plaque psoriasis (IGA 3 or 4 and BSA > 3%). Subjects were treated twice daily with IMPOYZ Cream or vehicle cream for 14 days. The primary endpoint was the proportion of subjects who achieved treatment success at Day 15, where treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade reduction from baseline.

The proportion of subjects who achieved treatment success was also assessed at Day 8 Table 1 presents the efficacy results at Day 8 and Day 15 Table 1. Treatment Success * Results * Treatment success is defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade reduction from baseline. Trial 1 Trial 2 IMPOYZ (N=178) Vehicle (N=89) IMPOYZ (N=176) Vehicle (N=89) Day 15 (primary endpoint) 30.2% 9.0% 30.1% 9.7% Day 8 (secondary endpoint) 15.7% 5.6% 14.2% 1.6%

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate cream. In a 13-week repeat dose toxicity study in rats, topical administration of clobetasol propionate cream, 0.001, 0.005 and 0.025% at corresponding doses of 0.004, 0.02 and 0.1 mg/kg/day resulted in corticosteroid class-related systemic effects such as reductions in body weight gain, reductions in total leukocytes and individual white cells, decrease in weight of adrenals, thymus, spleen, liver and lung.

Histologically, there were decreased hematopoiesis in the bone marrow, thymic atrophy and mast cell infiltration of the mesenteric lymph nodes. All these effects were indicative of severe immune suppression consistent with long-term exposure to corticosteroids. A no observable adverse effect level (NOAEL) was determined to be clobetasol propionate cream, 0.001% (0.004 mg/kg/day) in male rats while a NOAEL could not be determined in females.

The clinical relevance of the findings in animals to humans is not clear, but sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis. Clobetasol propionate was not mutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay , and the E. coli B WP2 fluctuation test. Fertility studies conducted in the rat following subcutaneous administration of clobetasol propionate at dosage levels up to 0.05 mg/kg/day revealed that females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate cream. In a 13-week repeat dose toxicity study in rats, topical administration of clobetasol propionate cream, 0.001, 0.005 and 0.025% at corresponding doses of 0.004, 0.02 and 0.1 mg/kg/day resulted in corticosteroid class-related systemic effects such as reductions in body weight gain, reductions in total leukocytes and individual white cells, decrease in weight of adrenals, thymus, spleen, liver and lung.

Histologically, there were decreased hematopoiesis in the bone marrow, thymic atrophy and mast cell infiltration of the mesenteric lymph nodes. All these effects were indicative of severe immune suppression consistent with long-term exposure to corticosteroids. A no observable adverse effect level (NOAEL) was determined to be clobetasol propionate cream, 0.001% (0.004 mg/kg/day) in male rats while a NOAEL could not be determined in females.

The clinical relevance of the findings in animals to humans is not clear, but sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis. Clobetasol propionate was not mutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay , and the E. coli B WP2 fluctuation test. Fertility studies conducted in the rat following subcutaneous administration of clobetasol propionate at dosage levels up to 0.05 mg/kg/day revealed that females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

📖 Instructions for Use ~3 min read ▾

PATIENT INFORMATION IMPOYZ® (Im-poise) (clobetasol propionate) Cream, 0.025% Important: IMPOYZ Cream is for use on the skin only. Do not get IMPOYZ Cream near or in your eyes, mouth, or vagina. What is IMPOYZ Cream?

IMPOYZ Cream is a prescription corticosteroid medicine used to treat moderate to severe plaque psoriasis in people 18 year of age and older. It is not known if IMPOYZ Cream is safe and effective in children under 18 years of age. IMPOYZ Cream is not recommended for use in children under 18 years of age.

Before using IMPOYZ Cream, tell your doctor about all of your medical conditions , including if you: have thinning of the skin (atrophy) at the treatment site. have a skin infection. You may need medicine to treat the skin infection before using IMPOYZ Cream. have diabetes. have adrenal gland problems. plan to have surgery. liver problems are pregnant or plan to become pregnant. It is not known if IMPOYZ Cream will harm your unborn baby.

If you use IMPOYZ Cream during pregnancy, use IMPOYZ Cream on the smallest area of skin and for the shortest time needed. are breastfeeding or plan to breastfeed. It is not known if IMPOYZ Cream passes into breast milk. Breastfeeding women should use IMPOYZ Cream on the smallest area of skin and for the shortest time needed while breastfeeding.

Do not apply IMPOYZ Cream directly to the nipple and areola to avoid contact with your baby. Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mount or use other products on your skin that contain corticosteroids.

Do not use other product containing a corticosteroid medicine with IMPOYZ Cream without talking to your doctor first. How should I use IMPOYZ Cream? Use IMPOYZ Cream exactly as your doctor tells you to use it Your doctor should tell you how much IMPOYZ Cream to use and where to apply it.

Apply a thin layer of IMPOYZ Cream to the affected skin areas 2 times each day and rub in gently and completely. Use IMPOYZ Cream for the shortest amount of time needed to treat your plaque psoriasis. Tell your doctor if your skin condition is not getting better after 2 weeks for using IMPOYZ.

Do not use IMPOYZ Cream for longer than 2 weeks in a row. Do not use IMPOYZ Cream on your face, scalp, underarms (armpits), groin, or areas where your skin may touch or rub together. Do not use IMPOYZ Cream if thinning of the skin atrophy is present at the treatment site.

Do not bandage, cover, or wrap the treated skin area unless your doctor tells you to. Wash your hand after you apply IMPOYZ Cream. See your doctor regularly to check your symptom and side effects while using IMPOYZ Cream.

What are the possible side effects of IMPOYZ Cream? IMPOYZ Cream may cause serious side effects, including: Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment with IMPOYZ Cream. Your doctor may do blood tests to check for adrenal gland problems during treatment with IMPOYZ Cream.

Cushing syndrome , a condition that can happen when your body is exposed to too much of the hormone cortisol. Your doctor may do tests to check for this. High blood sugar (hyperglycemia) or diabetes mellitus that has not been diagnosed can happened with treatment.

Your doctor may do tests to check for this. Skin reactions at the treated skin site. Tell your doctor if you get any skin reactions or skin infections.

Effects on growth and weight in children. The most common side effect of IMPOYZ Cream includes discoloration of the treated site. This is not the only possible side effect of IMPOYZ Cream.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store IMPOYZ Cream?

Store IMPOYZ Cream between 68°F to 77°F (20°C to 25°C). Do not freeze. Throw away (discard) any… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 160 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 68040-713-38 - 100 g Tube Label NDC 68040-713-38 Net Wt. 100 g Rx only impoyz ® (clobetasol propionate) Cream, 0.025% FOR TOPICAL USE ONLY NOT FOR ORAL, OPHTHALMIC OR INTRAVAGINAL USE Tube Label

PRINCIPAL DISPLAY PANEL - NDC: 68040-713-38 - 100 g Carton Label NDC 68040-713-38 Net Wt. 100 g Rx only impoyz ® (clobetasol propionate) Cream, 0.025% FOR TOPICAL USE ONLY NOT FOR ORAL, OPHTHALMIC OR INTRAVAGINAL USE Carton Label

PRINCIPAL DISPLAY PANEL - NDC: 68040-713-44 - 2.5 g Sample Tube Label NDC 68040-713-44 SAMPLE Not for individual sale 2.5 g Rx only impoyz ® (clobetasol propionate) Cream, 0.025% FOR TOPICAL USE ONLY Sample Tube Label

PRINCIPAL DISPLAY PANEL - NDC: 68040-713-44 - 2.5 g Sample Carton Label NDC 68040-713-44 Rx only Sample - Not for individual sale Contains twenty individual 2.5 g tubes impoyz ® (clobetasol propionate) Cream, 0.025% FOR TOPICAL USE ONLY NOT FOR ORAL, OPHTHALMIC OR INTRAVAGINAL USE Sample Carton Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Clobetasol Propionate (matched by generic name) — the program that covers self-administered drugs. 22 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Clobetasol Propionate. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$28.79M
Claims incl. refills
813.5K
Beneficiaries
629K
Spend / beneficiary
$45.78
Spend / claim
$35.39
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Impoyz (this brand).

Top reported reactions

Pruritus905
Rash654
Psoriasis541
Fatigue511
Headache488
Diarrhoea436
Nausea432

Reporter sex

10,253 reports
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,338 475
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Primus Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 20 tubes (68040-0713-44). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Primus Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68034-0101-00 · GMT 68040-0714-28 · Primus →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.