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CLOBETASOL PROPIONATE .5 mg/mL Solution — NDC 21922-0061-27 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CLOBETASOL PROPIONATE .5 mg/mL Solution — NDC 21922-061-27 (Billing 21922-0061-27)

by Encube Ethicals, Inc. · 1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE

This is a package of CLOBETASOL PROPIONATE .5 mg/mL Solution from Encube Ethicals, Inc., marketed since Jun 2024 and currently FDA-listed; retail pharmacies pay about $0.1359 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 21922-0061-27
🏷️ FDA NDC (as labeled) 21922-061-27 billing pads the product segment with a zero
This package
Contains50 mL in 1 bottle Cost per mL$0.1359 NADAC Per package$6.80 / 50 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3778/unit · Part D plans $0.3488/unit — full pricing hub ↓
Main listing for product 21922-061 · Also comes in: 25 mL 21922-061-22
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 20, 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

⚠️
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) 21922-061-27
Product NDC 21922-061
11-digit billing NDC 21922006127
NCPDP billing unit ML — per mL (volume)
RxCUI 861487
UNII 779619577M
Application # ANDA076977
SPL Set ID 8ad5f9b0-b50a-4d1f-a0c1-704b5b72bf65
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 2024-06-10
Route TOPICAL
Dosage form SOLUTION
Substance CLOBETASOL PROPIONATE
TE code (Orange Book) AT · RLD · RS

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

GCN Seq No 015349
GCN 15891
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% SOLUTION
FDB brand name Clobetasol Propionate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 015349
  • GCN: 15891
  • HICL (First Databank): 003327
  • AHFS class code: 84:06.08.00
  • RxCUI (RxNorm): 861487
Why two NDCs? The FDA registers this code as 21922-061-27 — 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 → 21922-0061-27. 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 CLOBETASOL 0.05% SOLUTION Ingredient Clobetasol Propionate
📗 Our plain-language guide HelloPharmacist
  • It calms inflamed, itchy skin and scalp conditions, including plaque psoriasis. The exact use depends on your product, such as shampoo for scalp psoriasis or spray for plaque psori...
  • Usually only a short time, often 2 weeks and up to 4 weeks for some products. Stop when your skin is under control. If you see no improvement in 2 weeks, check back with your presc...
  • Generally no. Most clobetasol skin products should not be used on the face, armpits or groin. Keep it out of your eyes and mouth, and follow your product's directions.
  • Mild burning, stinging, itching or dryness where you apply it. Call your doctor if your skin thins, breaks out, looks infected or gets worse. Also call for signs of steroid effects...
📖 Read our full Clobetasol 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 mLPer package
Retail pharmacies payNADAC · weekly $0.136 $6.80 / 50 ml
Medicaid paysCMS SDUD · 12 mo $0.3778 $18.89 / 50 ml
Medicare drug plans payPart D · Q2 2026 $0.3488 $17.44 / 50 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.136 $0.115
▲ Up 9% over the last 10 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
21922-0061-22 21922-061-22 1 BOTTLE in 1 CARTON / 25 mL in 1 BOTTLE $0.2401 / mL $6.00 2024-06-10 — Active
21922-0061-27 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE $0.1359 / mL $6.80 2024-06-10 — Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.1359 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 74% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 carton / 50 ml in 1 bottle.
What NDC number is used to bill for this package of CLOBETASOL PROPIONATE .5 mg/mL Solution?
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.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
clobetasol propionate .5 mg/mL 43386-0028-60 Lupin 1 bottle $0.120 AT FDA listed save 11%
Clobetasol Propionate .5 mg/mL 00168-0269-50 E. 50 ml $0.136 AT Availability likely —
Clobetasol Propionate .5 mg/mLthis 21922-0061-27 Encube 1 bottle $0.136 AT Availability likely —
Clobetasol Propionate .5 mg/mL 70752-0153-04 Quagen 1 bottle $0.136 AT Availability likely —
Clobetasol Propionate .5 mg/mL 42571-0362-81 Micro 1 bottle $0.240 AT Availability likely +77%
Clobetasol Propionate .5 mg/mL 51672-1293-02 Sun 1 bottle $0.240 AT Availability likely +77%
Clobetasol Propionate .5 mg/mL 62332-0486-25 Alembic 1 bottle $0.240 AT Availability likely +77%
Clobetasol Propionate .5 mg/mL 68462-0532-28 Glenmark 1 bottle $0.362 — FDA listed +166%
Clobetasol Propionate .4625 mg/mL 33342-0321-39 Macleods 1 bottle — AT FDA listed —
clobetasol propionate .5 mg/mL 40032-0028-60 Novel 1 bottle — AT FDA listed —
Clobetasol Propionate .5 mg/mL 46708-0486-25 Alembic 1 bottle — AT FDA listed —
Clobetasol Propionate .5 mg/mL 50090-5264-00 A-S 1 bottle — AT FDA listed —
Clobetasol Propionate .5 mg/mL 51407-0737-25 Golden 1 bottle — AT 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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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.

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 HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • 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 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

LabelerEncube Ethicals, Inc.
Application holderENCUBE ETHICALS PRIVATE LTD
FDA applicationANDA076977 (ANDA)
Labeler code21922
First marketedJun 2024
Product typeHuman Prescription Drug
Portfolio77 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.

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 ⛔ Contraindications 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 72 words ▾

INDICATIONS AND USAGE Clobetasol Propionate Topical Solution, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.

⏱️ Dosage and Administration 106 words ▾

DOSAGE AND ADMINISTRATION Clobetasol Propionate Topical Solution, 0.05% should be applied to the affected scalp areas twice daily, once in the morning and once at night. Clobetasol Propionate Topical Solution, 0.05% is potent; therefore, treatment must be limited to 2 consecutive weeks and amounts greater than 50 mL/week should not be used. Clobetasol Propionate Topical Solution, 0.05% is not to be used with occlusive dressings.

Geriatric Use In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with Clobetasol Propionate Topical Solution USP, 0.05%, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

⛔ Contraindications 33 words ▾

CONTRAINDICATIONS Clobetasol Propionate Topical Solution, 0.05% is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

🤒 Adverse Reactions 219 words ▾

ADVERSE REACTIONS Clobetasol Propionate Topical Solution, 0.05% is generally well tolerated when used for 2-week treatment periods. The most frequent adverse events reported for Clobetasol Propionate Topical Solution, 0.05% have been local and have included burning and/or stinging sensation, which occurred in 29 of 294 patients; scalp pustules, which occurred in 3 of 294 patients; and tingling and folliculitis, each of which occurred in 2 of 294 patients. Less frequent adverse events were itching and tightness of the scalp, dermatitis, tenderness, headache, hair loss, and eye irritation, each of which occurred in 1 of 294 patients.

The following local adverse reactions are reported infrequently when topical corticosteroids are used as recommended. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria in some patients.

In rare instances, treatment (or withdrawal of treatment) of psoriasis with corticosteroids is thought to have exacerbated the disease or provoked the pustular form of the disease, so careful patient supervision is recommended. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 215 words ▾

Pregnancy Teratogenic Effects: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse.

Clobetasol propionate has greater teratogenic potential than steroids that are less potent. Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of Clobetasol Propionate Topical Solution, 0.05%.

Abnormalities seen included cleft palate and skeletal abnormalities. In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of Clobetasol Propionate Topical Solution, 0.05%.

Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Clobetasol Propionate Topical Solution, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 101 words ▾

Pediatric Use Use of Clobetasol Propionate Topical Solution, 0.05% in pediatric patients under 12 years of age is not recommended. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing syndrome than mature patients because of a larger skin surface area to body weight ratio. HPA axis suppression, Cushing 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 81 words ▾

Geriatric Use A limited number of patients at or above 65 years of age (n=65) have been treated with Clobetasol Propionate Topical Solution, 0.05% in US and non US clinical trials. While the number of patients is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of Clobetasol Propionate Topical Solution, 0.05% in geriatric patients is warranted.

🆘 Overdosage 21 words ▾

OVERDOSAGE Topically applied Clobetasol Propionate Topical Solution, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions.

However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids, including clobetasol propionate, is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings (see DOSAGE AND ADMINISTRATION ).

As with all topical corticosteroids, clobetasol propionate can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION ).

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similarly to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys.

Some of the topical corticosteroids, including clobetasol propionate and its metabolites, are also excreted into the bile. Following repeated nonocclusive application in the treatment of scalp psoriasis, there is some evidence that Clobetasol Propionate Topical Solution, 0.05% has the potential to depress plasma cortisol levels in some patients. However, hypothalamic-pituitary-adrenal (HPA) axis effects produced by systemically absorbed clobetasol propionate have been shown to be transient and reversible upon completion of a 2-week course of treatment.

📦 How Supplied / Storage and Handling 94 words ▾

HOW SUPPLIED Clobetasol Propionate Topical Solution USP, 0.05% is supplied in plastic squeeze bottles, 25 mL (NDC 21922-061-22) and 50 mL (NDC 21922-061-27). Store in tight containers. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Do not refrigerate . Do not use near an open flame. Product of Italy, Formulated in India.

Manufactured by: Encube Ethicals Pvt. Ltd. Plot No.

C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Rev.

04/26

📋 Description 106 words ▾

DESCRIPTION Clobetasol Propionate Topical Solution USP, 0.05% contains 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. Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)pregna-1,4-diene-3,20-dione, and it has the following structural formula: Clobetasol propionate has the molecular formula C 25 H 32 ClFO 5 and a molecular weight of 467.

It is a white to cream-colored crystalline powder insoluble in water. Clobetasol Propionate Topical Solution USP, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbopol 974P, isopropyl alcohol (39.3%), purified water and sodium hydroxide. Structure

💬 Information for Patients 101 words ▾

Information for Patients Patients using Clobetasol Propionate Topical Solution, 0.05% should receive the following information and instructions: 1. This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. 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 or otherwise covered or wrapped so as to be occlusive. 4.

Patients should report any signs of local adverse reactions to the physician.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g (of ointment) per day. Systemic absorption of topical corticosteroids has resulted in reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria in some patients. Conditions that augment systemic absorption include the application of the more potent corticosteroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.

Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS: Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

Irritation is possible if Clobetasol Propionate Topical Solution, 0.05% contacts the eye. If that should occur, immediate flushing of the eye with a large volume of water is recommended. If the inflammatory lesion becomes infected, the use of an appropriate antifungal or antibacterial agent should be instituted.

If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Although Clobetasol Propionate Topical Solution, 0.05% is intended for the treatment of inflammatory conditions of the scalp, it should be noted that certain areas of the body, such as the face, groin, and axillae, are more prone to atrophic changes than other areas of the body following treatment with corticosteroids. Frequent observation of the patient is important if these areas are to be treated.

As with other potent topical corticosteroids, Clobetasol Propionate Topical Solution, 0.05% should not be used in the treatment of rosacea and perioral dermatitis. Topical corticosteroids in general should not be used in the treatment of acne or as sole therapy in widespread plaque psoriasis. Information for Patients Patients using Clobetasol Propionate Topical Solution, 0.05% should receive the following information and instructions: 1.

This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. 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 or otherwise covered or wrapped so as to be occlusive. 4. Patients should report any signs of local adverse reactions to the physician.

Laboratory Tests The following tests may be helpful in evaluating patients for HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay and the E. coli B WP2 fluctuation test. Pregnancy Teratogenic Effects: Corticosteroids have been sho… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 69 words ▾

Nursing Mothers 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 corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Topical Solution, 0.05% is administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 88 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Studies in the rat following subcutaneous administration at dosage levels up to 50 mcg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose. Clobetasol propionate was nonmutagenic in 3 different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay and the E. coli B WP2 fluctuation test.

📄 Package Label / Principal Display Panel 50 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 21922- 061 -22 Clobetasol Propionate Topical Solution USP, 0.05% FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE . Rx only 25mL NDC 21922- 061 -27 Clobetasol Propionate Topical Solution USP, 0.05% FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE . Rx only 50mL carton-25ml carton-50ml

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
25.3K
Units reimbursed last 4 qtrs
1.4M
Gross reimbursed last 4 qtrs
$510.3K
Avg / prescription
$20.17
Avg / unit
$0.3778
Latest quarter Q1 2026
8.2KRx
Medicaid pays / mL
$0.3778
gross reimbursed
vs
NADAC / mL
$0.1359
acquisition cost
=
Spread
+$0.2419
+178% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
37% FFS 63% MCO
Fee-for-service · 9,274 Rx Managed care · 16,024 Rx
State Medicaid map
Alaska: 6,700 units · 914 per 100k residents AK Maine: no data reported ME Washington: 75,850 units · 971 per 100k residents WA Idaho: 7,100 units · 362 per 100k residents ID Montana: 2,000 units · 177 per 100k residents MT North Dakota: no data reported ND Minnesota: 27,600 units · 481 per 100k residents MN Wisconsin: 22,900 units · 387 per 100k residents WI Michigan: 79,900 units · 796 per 100k residents MI New York: 137,475 units · 702 per 100k residents NY Vermont: no data reported VT New Hampshire: 2,250 units · 160 per 100k residents NH Oregon: 35,900 units · 848 per 100k residents OR Nevada: 16,100 units · 504 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,600 units · 174 per 100k residents SD Iowa: 28,455 units · 887 per 100k residents IA Illinois: 10,000 units · 79.7 per 100k residents IL Indiana: 24,800 units · 361 per 100k residents IN Ohio: 86,410 units · 733 per 100k residents OH Pennsylvania: 44,800 units · 346 per 100k residents PA New Jersey: 31,050 units · 334 per 100k residents NJ Massachusetts: 1,150 units · 16.4 per 100k residents MA California: 204,672 units · 525 per 100k residents CA Utah: 19,950 units · 584 per 100k residents UT Colorado: 20,200 units · 344 per 100k residents CO Nebraska: 8,700 units · 440 per 100k residents NE Missouri: 15,275 units · 247 per 100k residents MO Kentucky: 35,810 units · 791 per 100k residents KY West Virginia: 22,750 units · 1,285 per 100k residents WV Virginia: 35,300 units · 405 per 100k residents VA Maryland: 5,850 units · 94.7 per 100k residents MD Connecticut: 7,650 units · 212 per 100k residents CT Rhode Island: no data reported RI Arizona: 58,750 units · 791 per 100k residents AZ New Mexico: 3,150 units · 149 per 100k residents NM Kansas: 3,550 units · 121 per 100k residents KS Arkansas: 5,725 units · 187 per 100k residents AR Tennessee: 35,210 units · 494 per 100k residents TN North Carolina: 58,025 units · 536 per 100k residents NC South Carolina: 11,550 units · 215 per 100k residents SC Delaware: 2,050 units · 199 per 100k residents DE Oklahoma: 5,801 units · 143 per 100k residents OK Louisiana: 21,409 units · 468 per 100k residents LA Mississippi: 1,550 units · 52.7 per 100k residents MS Alabama: 11,260 units · 220 per 100k residents AL Georgia: 34,650 units · 314 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 18,600 units · 61.0 per 100k residents TX Florida: 61,510 units · 272 per 100k residents FL
Units reimbursed · per 100k residents
16.41,285
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 West Virginia 1,285 /100k
2 Washington 971 /100k
3 Alaska 914 /100k
4 Iowa 887 /100k
5 Oregon 848 /100k
6 Michigan 796 /100k
7 Kentucky 791 /100k
8 Arizona 791 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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.
1 bottle this page21922-0061-27 25,298 Rx · $510,345
1 bottle21922-0061-22 8,774 Rx · $148,975
Drug total (last 4 qtrs): 34,072 Rx · 1,666,342 units · $659,320 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.
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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.