Clobetasol Propionate .5 mg/g Gel
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
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 ↗- 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clobetasol Propionate — tap one for details:
Clobetasol may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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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.
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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.
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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.
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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?
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?
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Can inactive ingredients matter?
💲 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 system | Per g | Per 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 · Q2 2026 | $0.2669 | $4.00 / 15 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| clobetasol propionate .5 mg/g 43386-0096-60 | Lupin | 1 tube | $0.129 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 00713-0656-15 | Cosette | 1 tube | $0.129 | AB | Availability likely | — |
| Clobetasol Propionate ANDA .5 mg/g 33342-0506-15 | Macleods | 1 tube | $0.129 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 70700-0106-15 | Xiromed, | 15 g | $0.129 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 59651-0732-14 | Aurobindo | 1 tube | $0.129 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 51672-1259-01 | Sun | 1 tube | $0.129 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 72603-0855-01 | NorthStar | 1 tube | $0.129 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 62332-0465-15 | Alembic | 1 tube | $0.129 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 69238-1532-03 | Amneal | 1 tube | $0.168 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 51672-1258-01 | Sun | 1 tube | $0.188 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 70700-0109-15 | Xiromed, | 1 tube | $0.188 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 62332-0547-15 | Alembic | 1 tube | $0.188 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 13668-0569-01 | Torrent | 15 g | $0.188 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 00168-0163-15 | E. | 15 g | $0.188 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 68180-0956-01 | Lupin | 1 tube | $0.188 | AB1 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 68462-0529-17 | Glenmark | 1 tube | $0.224 | — | FDA listed | — |
| Clobetasol Propionate .5 mg/g 00168-0162-15 | E. | 15 g | $0.295 | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 70710-1401-01 | Zydus | 1 tube | $0.329 | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 68462-0530-17 | Glenmark | 1 tube | $0.329 | — | FDA listed | — |
| Clobetasol Propionate .5 mg/g 16714-0782-01 | Northstar | 1 tube | $0.329 | — | Discontinued | — |
| Clobetasol Propionate (emollient) .5 mg/g 00168-0301-15 | E. | 1 tube | $0.590 | AB2 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 51672-1297-01 | Sun | 1 tube | $0.597 | AB2 | Availability likely | — |
| Clobetasol Propionate (emollient) .5 mg/g 83148-0064-15 | The | 1 tube | $0.597 | AB2 | Availability likely | — |
| Clobetasol Propionate .5 mg/g 00168-0293-15 | E. | 15 g | $0.666 | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 45802-0925-14 | Padagis | 1 tube | $0.710 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/g 51672-1294-01 | Sun | 1 tube | $0.710 | AB | Availability likely | — |
| Clobetasol Propionate .5 mg/gthis 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 | — |
Where does this data come from?
⏳ Availability & generic status
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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63629-8637-01 You're viewing this | 1 TUBE in 1 CARTON (63629-8637-1) / 15 g in 1 TUBE | 2008-07-30 | Active |
🧭 About this NDC listing & data coverage
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. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clobetasol Propionate Gel, 0.05% is a super-high potency corticosteroid formulation 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/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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply a thin layer of Clobetasol Propionate Gel, 0.05% to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE ). Clobetasol Propionate Gel, 0.05% is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/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, 0.05% should not be used with occlusive dressings.
⛔ Contraindications ▾
CONTRAINDICATIONS Clobetasol Propionate Gel, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In a controlled trial with clobetasol propionate gel, 0.05%, the only reported adverse reaction that was considered to be drug related was a report of burning sensation (1.8% of treated patients). In larger controlled clinical trials with other clobetasol propionate formulations, the most frequently reported adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of fingers, skin atrophy, and telangiectasia (all less than 2%).
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 are reported infrequently with topical corticosteroids, but may occur more frequently with super-high potency corticosteroids such as Clobetasol Propionate Gel, 0.05%. These reactions are listed in approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects: Pregnancy Category C - 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 gel.
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 gel.
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 Gel, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use - Safety and effectiveness of Clobetasol Propionate Gel, 0.05% in children and infants have not been established; therefore, use in children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency after withdrawal of treatment and of Cushing’s syndrome while on 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, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
🧓 Geriatric Use ▾
Geriatric Use - Clinical studies of clobetasol propionate gel, 0.05% 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 ▾
OVERDOSAGE Topically applied Clobetasol Propionate Gel, 0.05% can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
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 dressing 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, 0.05% indicate that it is in the super-high range of potency as compared with other topical corticosteroids.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clobetasol Propionate Gel, 0.05% is available as follows: 15 g tube (NDC 63629-8637-1)
📦 Storage and Handling ▾
STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Clobetasol Propionate Gel, 0.05% should not be refrigerated. Made in Israel Manufactured By Perrigo Yeruham, Israel Distributed By Perrigo® Allegan, MI 49010 – www.perrigo.com Rev 01-19 : 2P100 RC J5
📋 Description ▾
DESCRIPTION Clobetasol Propionate Gel, 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 (11ß,16ß)-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 empirical 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 Gel, 0.05% contains clobetasol propionate 0.5 mg/g in a base of carbomer homopolymer type B, propylene glycol, purified water, and sodium hydroxide. structural_formula
💬 Information for Patients ▾
Information for Patients - Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
This medication should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions to the physician.
Patients should inform their physicians that they are using Clobetasol Propionate Gel, 0.05% if surgery is contemplated.