HomeNDC LookupIngredientsClobetasol Propionate › 00168-0293-30
Clobetasol Propionate .5 mg/g Gel, 30 g — NDC 00168-0293-30 package photo

Clobetasol Propionate .5 mg/g Gel, 30 g

by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. · 30 g in 1 TUBE (0168-0293-30)
NDC 00168-0293-30
🏷️ FDA NDC (as labeled) 0168-0293-30 billing pads the labeler segment with a zero
This package
Contains30 g Cost per g$0.6533 NADAC Per package$19.60 / 30 g Pack sizes3 compare ↓
Also priced by: Part D plans $0.2669/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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

FDA NDC (as labeled) 0168-0293-30
Product NDC 0168-0293
11-digit billing NDC 00168029330
NCPDP billing unit GM — per gram (weight)
RxCUI 861434, 861448, 861495
UNII 779619577M
UPC 0301680162157, 0301680293158, 0301680163154
Application # ANDA075368
SPL Set ID 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-02-15
Route TOPICAL
Dosage form GEL
Substance CLOBETASOL PROPIONATE
GPI-14 90550025104010
GPI class Clobetasol Propionate
GCN Seq No 021904
GCN 15892
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 CLOBETASOL 0.05% GEL
FDB brand name Clobetasol Propionate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 0168-0293-30 — a 4-4-2 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 labeler segment → 00168-0293-30. 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.

🏭 Manufacturer & labeler

LabelerE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application holderFOUGERA PHARMACEUTICALS INC
FDA applicationANDA075368 (ANDA)
Labeler code00168
First marketedFeb 2000
Product typeHuman Prescription Drug
Portfolio7 products on file
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.

🩺 Clinical

Label name CLOBETASOL 0.05% GEL 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 is a very strong prescription steroid cream (or foam, spray, shampoo, solution, or eye drop) used to calm inflamed, itchy skin. Depending on the specific product, it tre...
  • That's a really important question. Most clobetasol skin products should be used for no more than 2 consecutive weeks. Some formulations can be extended to 4 weeks for certain case...
  • How long can I use this? I've heard you can't use steroids for too long.
  • Do not apply clobetasol to your face, underarms, or groin unless your doctor has specifically told you to — those areas absorb much more of the medication. Also avoid any skin that...
📖 Read our full Clobetasol guide →

Supplement & herbal interactions

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

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.

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.

🧪 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.

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

  • UNII Z135WT9208
    Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective 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.

4 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 DailyMedingredient 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.

💲 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 $0.653 $19.60 / 30 g
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 · Q2 2026 $0.2669 $8.01 / 30 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Aug 2022 Nov 2023 Feb 2026 $1.619 $0.432
▼ Down 60% over the last 13 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
clobetasol propionate .5 mg/g 43386-0096-60 Lupin 1 tube $0.129 AB Availability likely save 80%
Clobetasol Propionate .5 mg/g 00713-0656-15 Cosette 1 tube $0.129 AB Availability likely save 80%
Clobetasol Propionate ANDA .5 mg/g 33342-0506-15 Macleods 1 tube $0.129 AB Availability likely save 80%
Clobetasol Propionate .5 mg/g 70700-0106-15 Xiromed, 15 g $0.129 AB Availability likely save 80%
Clobetasol Propionate .5 mg/g 59651-0732-14 Aurobindo 1 tube $0.129 AB Availability likely save 80%
Clobetasol Propionate .5 mg/g 51672-1259-01 Sun 1 tube $0.129 AB Availability likely save 80%
Clobetasol Propionate .5 mg/g 72603-0855-01 NorthStar 1 tube $0.129 AB Availability likely save 80%
Clobetasol Propionate .5 mg/g 62332-0465-15 Alembic 1 tube $0.129 AB Availability likely save 80%
Clobetasol Propionate .5 mg/g 69238-1532-03 Amneal 1 tube $0.168 AB1 Availability likely save 74%
Clobetasol Propionate .5 mg/g 51672-1258-01 Sun 1 tube $0.188 AB1 Availability likely save 71%
Clobetasol Propionate .5 mg/g 70700-0109-15 Xiromed, 1 tube $0.188 AB1 Availability likely save 71%
Clobetasol Propionate .5 mg/g 62332-0547-15 Alembic 1 tube $0.188 AB1 Availability likely save 71%
Clobetasol Propionate .5 mg/g 13668-0569-01 Torrent 15 g $0.188 AB1 Availability likely save 71%
Clobetasol Propionate .5 mg/g 00168-0163-15 E. 15 g $0.188 AB1 Availability likely save 71%
Clobetasol Propionate .5 mg/g 68180-0956-01 Lupin 1 tube $0.188 AB1 Availability likely save 71%
Clobetasol Propionate .5 mg/g 68462-0529-17 Glenmark 1 tube $0.224 FDA listed save 66%
Clobetasol Propionate .5 mg/g 00168-0162-15 E. 15 g $0.295 AB FDA listed save 55%
Clobetasol Propionate .5 mg/g 70710-1401-01 Zydus 1 tube $0.329 AB FDA listed save 50%
Clobetasol Propionate .5 mg/g 68462-0530-17 Glenmark 1 tube $0.329 FDA listed save 50%
Clobetasol Propionate .5 mg/g 16714-0782-01 Northstar 1 tube $0.329 Discontinued save 50%
Clobetasol Propionate (emollient) .5 mg/g 00168-0301-15 E. 1 tube $0.590 AB2 Availability likely save 10%
Clobetasol Propionate .5 mg/g 51672-1297-01 Sun 1 tube $0.597 AB2 Availability likely save 9%
Clobetasol Propionate (emollient) .5 mg/g 83148-0064-15 The 1 tube $0.597 AB2 Availability likely save 9%
Clobetasol Propionate .5 mg/gthis 00168-0293-30 E. 30 g $0.653 AB FDA listed
Clobetasol Propionate .5 mg/g 45802-0925-14 Padagis 1 tube $0.710 AB Availability likely +9%
Clobetasol Propionate .5 mg/g 51672-1294-01 Sun 1 tube $0.710 AB Availability likely +9%
Clobetasol Propionate .5 mg/g 63629-8637-01 Bryant 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 63629-8638-01 Bryant 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 63629-8639-01 Bryant 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 72162-1438-02 Bryant 1 tube AB FDA listed
clobetasol propionate .5 mg/g 40032-0096-60 Novel 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 42291-0077-15 AvKARE 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 50090-0549-00 A-S 1 tube AB1 FDA listed
Clobetasol Propionate .5 mg/g 50090-5079-00 A-S 1 tube AB1 FDA listed
Clobetasol Propionate .5 mg/g 50090-5488-00 A-S 1 tube FDA listed
Clobetasol Propionate .5 mg/g 50090-6402-00 A-S 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 50090-6717-00 A-S 1 tube AB1 FDA listed
Clobetasol Propionate .5 mg/g 63629-2331-01 Bryant 1 tube AB1 FDA listed
Clobetasol Propionate .5 mg/g 46708-0465-15 Alembic 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 63629-2332-01 Bryant 1 tube AB1 FDA listed
Clobetasol Propionate .5 mg/g 68071-3922-05 NuCare 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 70771-1209-01 Zydus 1 tube AB FDA listed
Clobetasol Propionate .5 mg/g 46708-0547-15 Alembic 1 tube AB1 FDA listed
Clobetasol Propionate .5 mg/g 82804-0083-30 Proficient 30 g AB1 FDA listed
Clobetasol Propionate .5 mg/g 72162-1961-02 Bryant 1 tube AB1 FDA listed
Clobetasol Propionate (emollient) .5 mg/g 72162-2628-02 Bryant 1 tube AB2 FDA listed
Clobetasol Propionate .5 mg/g 72189-0262-30 DIRECT 30 g AB1 FDA listed
Clobetasol Propionate .5 mg/g 63629-2329-01 Bryant 60 g AB1 FDA listed
Clobetasol Propionate .5 mg/g 63629-2330-01 Bryant 1 tube AB1 FDA listed
Clobetasol Propionate .5 mg/g 42291-0076-15 AvKARE 1 tube AB1 FDA listed
Clobetasol Propionate .5 mg/g 50090-8001-00 A-S 1 tube AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2000
On the market since
Feb 2000
📍
2026
Currently FDA-listed
26 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
15 gs00168-0293-15 25 Rx · $1,044
60 gs00168-0293-60 18 Rx · $572
30 gs this page00168-0293-30 No Medicaid data
Drug total (last 4 qtrs): 43 Rx · 2,100 units · $1,616 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Clobetasol Propionate — 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. 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 Clobetasol Propionate — the ingredient across all brands.

Top reported reactions

Pruritus925
Rash667
Psoriasis550
Fatigue512
Headache493
Diarrhoea439
Nausea439

Age at onset

Neonate3
Infant4
Child79
Adolescent86
Adult1,895
Elderly1,258

Reporter sex

10,471 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization2,013
Life-threatening245
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,338 630
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00168-0293-15 15 g in 1 TUBE (0168-0293-15) $0.6658 / g $9.99 2000-02-15 Active
00168-0293-30 You're viewing this 30 g in 1 TUBE (0168-0293-30) $0.6533 / g $19.60 2000-02-15 Active
00168-0293-60 60 g in 1 TUBE (0168-0293-60) $0.4348 / g $26.09 2000-02-15 Active

You're viewing one of 3 pack sizes for this product.

Per g, this pack runs about 50% above the cheapest pack (60 g, $0.4348 vs $0.6533 NADAC).

Pack size FAQ

What quantity is in NDC 00168-0293-30?
NDC 00168-0293-30 contains 30 g — 30 g in 1 tube.
What is the difference between NDC 00168-0293-30 and NDC 00168-0293-15?
Both are Clobetasol Propionate .5 mg/g Gel — the drug itself is identical. NDC 00168-0293-30 is the 30 g package, while NDC 00168-0293-15 is the 15 g package. Per-g NADAC also differs: $0.6533 here vs $0.6658 for the 15 g pack.
What NDC number is used to bill for this package of Clobetasol Propionate .5 mg/g Gel?
Bill NDC 00168-0293-30 — the 11-digit billing format is 00168029330. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 102 words

INDICATIONS AND USAGE: Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. 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. Use in pediatric patients under 12 years of age is not recommended.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

⏱️ Dosage and Administration 106 words

DOSAGE AND ADMINISTRATION: Apply a thin layer of clobetasol propionate gel, cream or ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE. ) Clobetasol propionate gel, cream and ointment are super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved.

If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol propionate gel, cream and ointment should not be used with occlusive dressings.

Contraindications 25 words

CONTRAINDICATIONS: Clobetasol propionate gel, cream and ointment are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

🤒 Adverse Reactions 187 words

ADVERSE REACTIONS: In a controlled clinical trial with clobetasol propionate gel, the only reported adverse reaction that was considered to be drug related was a report of burning sensation (1.8% of treated patients). In controlled clinical trials, the most frequent adverse reactions reported for clobetasol propionate cream were burning and stinging sensation in 1% of treated patients. Less frequent adverse reactions were itching, skin atrophy, and cracking and fissuring of the skin.

In controlled clinical trials, the most frequent adverse events reported for clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia. Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

🧒 Pediatric Use 153 words

Pediatric Use: Safety and effectiveness of clobetasol propionate gel, cream and ointment in pediatric patients have not been established. Use in children under 12 years of age 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 HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids.

They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children (see PRECAUTIONS ). HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids.

Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

🧓 Geriatric Use 60 words

Geriatric Use: Clinical studies of clobetasol propionate drug products in US clinical trials did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

🆘 Overdosage 22 words

OVERDOSAGE: Topically applied clobetasol propionate gel, cream and ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology 206 words

CLINICAL PHARMACOLOGY: Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins.

It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier.

Occlusive dressings with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Greater absorption was observed for the clobetasol propionate gel formulation as compared to the cream formulation in in vitro human skin penetration studies. Studies performed with clobetasol propionate gel, cream and ointment indicate that they are in the super-high range of potency as compared with other topical corticosteroids.

📦 How Supplied / Storage and Handling 108 words

HOW SUPPLIED: Clobetasol Propionate Gel, 0.05% is supplied in tamper-evident tubes as follows: 15 g (NDC 0168-0293-15) 30 g (NDC 0168-0293-30) 60 g (NDC 0168-0293-60) Clobetasol Propionate Cream USP, 0.05% is supplied in tamper-evident tubes as follows: 15 g (NDC 0168-0163-15) 30 g (NDC 0168-0163-30) 45 g (NDC 0168-0163-46) 60 g (NDC 0168-0163-60) Clobetasol Propionate Ointment USP, 0.05% is supplied in tamper-evident tubes as follows: 15 g (NDC 0168-0162-15) 30 g (NDC 0168-0162-30) 45 g (NDC 0168-0162-46) 60 g (NDC 0168-0162-60) Store at controlled room temperature 15°-30°C (59°-86°F).

DO NOT REFRIGERATE. E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I2162H R08/12 #202

📋 Description 148 words

DESCRIPTION: Clobetasol propionate gel, cream and ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water.

Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula: Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a base of propylene glycol, carbomer 934P, sodium hydroxide and purified water. Each gram of the 0.05% cream contains clobetasol propionate 0.5 mg in a cream base of propylene glycol, glyceryl monostearate, cetostearyl alcohol, glyceryl stearate/PEG 100 stearate, white wax, chlorocresol, sodium citrate anhydrous, citric acid anhydrous, and purified water.

Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum. StructuralFormula

💬 Information for Patients 107 words

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes. 2. This medication should not be used for any disorder other than that for which it was prescribed.

3. The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician. 4.

Patients should report any signs of local adverse reactions to the physician. 5. Patients should inform their physicians that they are using clobetasol propionate if surgery is contemplated.

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