Clobetasol Propionate .5 mg/g Cream
Past resolved recalls for this product (1)
🆔 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.
💊 What it looks like
Where does this data come from?
🧪 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 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 36W53O7109
Chlorocresol is a phenolic antimicrobial chemical used as a preservative in liquid medicines and injectable solutions. It prevents bacterial and fungal growth to maintain product safety and shelf-life.
-
UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
-
UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
-
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 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 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
-
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.
9 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?
Why might an inactive ingredient be missing?
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 | $0.116 | $5.21 / 45 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 | $12.01 / 45 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clobetasol Propionate .5 mg/gthis 68180-0956-03 | Lupin | 1 tube | $0.116 | AB1 | Availability likely | — |
| clobetasol propionate .5 mg/g 43386-0096-60 | Lupin | 1 tube | $0.129 | AB | Availability likely | +11% |
| Clobetasol Propionate .5 mg/g 00713-0656-15 | Cosette | 1 tube | $0.129 | AB | Availability likely | +11% |
| Clobetasol Propionate ANDA .5 mg/g 33342-0506-15 | Macleods | 1 tube | $0.129 | AB | Availability likely | +11% |
| Clobetasol Propionate .5 mg/g 70700-0106-15 | Xiromed, | 15 g | $0.129 | AB | Availability likely | +11% |
| Clobetasol Propionate .5 mg/g 59651-0732-14 | Aurobindo | 1 tube | $0.129 | AB | Availability likely | +11% |
| Clobetasol Propionate .5 mg/g 51672-1259-01 | Sun | 1 tube | $0.129 | AB | Availability likely | +11% |
| Clobetasol Propionate .5 mg/g 72603-0855-01 | NorthStar | 1 tube | $0.129 | AB | Availability likely | +11% |
| Clobetasol Propionate .5 mg/g 62332-0465-15 | Alembic | 1 tube | $0.129 | AB | Availability likely | +11% |
| Clobetasol Propionate .5 mg/g 69238-1532-03 | Amneal | 1 tube | $0.168 | AB1 | Availability likely | +45% |
| Clobetasol Propionate .5 mg/g 00168-0163-15 | E. | 15 g | $0.188 | AB1 | Availability likely | +63% |
| Clobetasol Propionate .5 mg/g 13668-0569-01 | Torrent | 15 g | $0.188 | AB1 | Availability likely | +63% |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 21922-0016-04 | Encube | 15 g | $0.188 | AB1 | Availability likely | +63% |
| Clobetasol Propionate .5 mg/g 51672-1258-01 | Sun | 1 tube | $0.188 | AB1 | Availability likely | +63% |
| Clobetasol Propionate .5 mg/g 62332-0547-15 | Alembic | 1 tube | $0.188 | AB1 | Availability likely | +63% |
| Clobetasol Propionate .5 mg/g 70700-0109-15 | Xiromed, | 1 tube | $0.188 | AB1 | Availability likely | +63% |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 72603-0323-01 | Northstar | 15 g | $0.188 | AB1 | Availability likely | +63% |
| Clobetasol Propionate .5 mg/g 68462-0529-17 | Glenmark | 1 tube | $0.224 | — | FDA listed | +93% |
| Clobetasol Propionate .5 mg/g 00168-0162-15 | E. | 15 g | $0.295 | AB | FDA listed | +155% |
| Clobetasol Propionate .5 mg/g 70710-1401-01 | Zydus | 1 tube | $0.329 | AB | FDA listed | +185% |
| Clobetasol Propionate .5 mg/g 68462-0530-17 | Glenmark | 1 tube | $0.329 | — | FDA listed | +185% |
| Clobetasol Propionate .5 mg/g 16714-0782-01 | Northstar | 1 tube | $0.329 | — | Discontinued | +185% |
| Clobetasol Propionate (emollient) .5 mg/g 00168-0301-15 | E. | 1 tube | $0.590 | AB2 | Availability likely | +409% |
| Clobetasol Propionate .5 mg/g 51672-1297-01 | Sun | 1 tube | $0.597 | AB2 | Availability likely | +415% |
| Clobetasol Propionate (emollient) .5 mg/g 83148-0064-15 | The | 1 tube | $0.597 | AB2 | Availability likely | +415% |
| Clobetasol Propionate .5 mg/g 00168-0293-15 | E. | 15 g | $0.666 | AB | FDA listed | +475% |
| Clobetasol Propionate .5 mg/g 45802-0925-14 | Padagis | 1 tube | $0.710 | AB | Availability likely | +513% |
| Clobetasol Propionate .5 mg/g 51672-1294-01 | Sun | 1 tube | $0.710 | AB | Availability likely | +513% |
| Clobetasol Propionate .5 mg/g 42291-0076-15 | AvKARE | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 46708-0547-15 | Alembic | 1 tube | — | AB1 | 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 Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 50090-5979-00 | A-S | 30 g | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 50090-6717-00 | A-S | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 50090-7392-00 | A-S | 15 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 63629-2331-01 | Bryant | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-2332-01 | Bryant | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate Cream 0.05% Clobetasol Propionate Cream 0.05% .5 mg/g 68788-4001-06 | Preferred | 60 g | — | AB1 | FDA listed | — |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 70518-4374-00 | REMEDYREPACK | 30 g | — | AB1 | FDA listed | — |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 71335-2821-01 | Bryant | 60 g | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 72162-1961-02 | Bryant | 1 tube | — | AB1 | FDA listed | — |
| Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g 72162-2300-02 | Bryant | 15 g | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 72189-0262-30 | DIRECT | 30 g | — | AB1 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 82804-0083-30 | Proficient | 30 g | — | AB1 | FDA listed | — |
| Clobetasol Propionate Cream, 0.05% Clobetasol Propionate Cream, 0.05% .5 mg/g 82804-0133-30 | Proficient | 30 g | — | AB1 | 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 50090-5488-00 | 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 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 46708-0465-15 | Alembic | 1 tube | — | AB | 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 72162-1438-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate (emollient) .5 mg/g 72162-2628-02 | Bryant | 1 tube | — | AB2 | FDA listed | — |
| Clobetasol Propionate .5 mg/g 63629-8639-01 | Bryant | 1 tube | — | AB | 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?
💊 Medicaid utilization by pack size
📊 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 | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68180-0956-01 | 1 TUBE in 1 CARTON (68180-956-01) / 15 g in 1 TUBE | $0.1884 / g | $2.83 | 2018-08-17 | Active |
| 68180-0956-02 | 1 TUBE in 1 CARTON (68180-956-02) / 30 g in 1 TUBE | $0.1681 / g | $5.04 | 2018-08-17 | Active |
| 68180-0956-03 You're viewing this | 1 TUBE in 1 CARTON (68180-956-03) / 45 g in 1 TUBE | $0.1158 / g | $5.21 | 2018-08-17 | Active |
| 68180-0956-04 | 1 TUBE in 1 CARTON (68180-956-04) / 60 g in 1 TUBE | $0.1427 / g | $8.56 | 2018-08-17 | Active |
This pack has the lowest per-g cost of the 4 priced pack sizes ($0.1158 NADAC).
This pack shows little to no recent Medicaid volume — a different pack size carries the largest share of fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 68180-0956-03?
What NDC number is used to bill for this package of Clobetasol Propionate .5 mg/g Cream?
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
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clobetasol propionate cream USP is 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 50g/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 ▾
DOSAGE AND ADMINISTRATION Apply a thin layer of clobetasol propionate cream USP to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE ). Clobetasol propionate cream is super-high potency topical corticosteroids; 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 cream should not 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 cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.
⛔ Contraindications ▾
CONTRAINDICATIONS Clobetasol propionate cream USP, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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. 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. To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 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 cream.
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 cream.
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 cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🆘 Overdosage ▾
OVERDOSAGE Topically applied clobetasol propionate cream 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.
Studies performed with clobetasol propionate cream indicate that they are in the super-high range of potency as compared with other topical corticosteroids.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clobetasol propionate cream USP, 0.05% is supplied in 15-g (NDC 68180-956-01), 30-g (NDC 68180-956-02), 45-g (NDC 68180-956-03), and 60-g (NDC 68180-956-04) tubes. Store between 15º to 30ºC (59º to 86ºF). Clobetasol propionate cream should not be refrigerated.
Rx only. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured for: Lupin Pharmaceuticals, Inc.
Naples, FL 34108 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 India November 2024 ID#: 278379 Image
📋 Description ▾
DESCRIPTION Clobetasol propionate cream USP, 0.05% 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. Chemically, clobetasol propionate 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: Clobetasol propionate has the empirical formula C 25 H 32 ClFO 5 and a molecular weight of 467.
It is a white to almost white crystalline powder insoluble in water. Clobetasol propionate cream USP contains clobetasol propionate USP 0.5 mg/g in a cream base of cetostearyl alcohol, chlorocresol, citric acid monohydrate, glyceryl monostearate, glyceryl stearate/ polyethylene glycol 100 stearate, propylene glycol, purified water, sodium citrate, and white wax. Image-01
💬 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.