Clobetasol Propionate (emollient) .5 mg/g Cream — NDC 0168-0301-30 (Billing 00168-0301-30)
This is a package of Clobetasol Propionate (emollient) .5 mg/g Cream from E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., no longer marketed (first marketed May 1999), no longer in the FDA NDC Directory; retail pharmacies pay about $0.8388 per g (NADAC).
NDC database record
One package, one record: these facts belong to NDC 0168-0301-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0168 labeler · 0301 product · 30 package
- Package marketed since
- May 26, 1999
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0301680301150
- Medicaid fills, this package
- 13 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Other active recalls for Clobetasol Propionate (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 021986
- GCN: 34141
- GPI-14 (Medi-Span): 90550025153705
- HICL (First Databank): 009061
- AHFS class code: 84:06.08.00
- RxCUI (RxNorm): 1992281
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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 ↗- 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...
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?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.839 | $25.16 / 30 g |
| Medicaid paysCMS SDUD · 12 mo | $0.9672 | $29.02 / 30 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Feb 21, 2024
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00168-0301-15 0168-0301-15 Main listing | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $0.5899 / g | $8.85 | 1999-05-26 | — | Discontinued by firm |
| 00168-0301-30 You're viewing this | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | $0.8388 / g | $25.16 | 1999-05-26 | — | Discontinued by firm |
| 00168-0301-60 0168-0301-60 | 1 TUBE in 1 CARTON / 60 g in 1 TUBE | $0.5620 / g | $33.72 | 1999-05-26 | — | Discontinued by firm |
Per g, this pack runs about 49% above the cheapest pack (NDC 00168-0301-60, $0.5620 vs $0.8388 NADAC).
This pack accounts for about 5.7% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Clobetasol Propionate (emollient) .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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| clobetasol propionate .5 mg/g 43386-0096-60 | Lupin | 1 tube | $0.138 | AB | Availability likely | save 84% |
| Clobetasol Propionate .5 mg/g 00713-0656-15 | Cosette | 1 tube | $0.138 | AB | Availability likely | save 84% |
| Clobetasol Propionate ANDA .5 mg/g 33342-0506-15 | Macleods | 1 tube | $0.138 | AB | Availability likely | save 84% |
| Clobetasol Propionate .5 mg/g 70700-0106-15 | Xiromed, | 15 g | $0.138 | AB | Availability likely | save 84% |
| Clobetasol Propionate .5 mg/g 59651-0732-14 | Aurobindo | 1 tube | $0.138 | AB | Availability likely | save 84% |
| Clobetasol Propionate .5 mg/g 51672-1259-01 | Sun | 1 tube | $0.138 | AB | Availability likely | save 84% |
| Clobetasol Propionate .5 mg/g 72603-0855-01 | NorthStar | 1 tube | $0.138 | AB | Availability likely | save 84% |
| Clobetasol Propionate .5 mg/g 62332-0465-15 | Alembic | 1 tube | $0.138 | AB | Availability likely | save 84% |
| Clobetasol Propionate .5 mg/g 69238-1532-03 | Amneal | 1 tube | $0.167 | AB1 | Availability likely | save 80% |
| Clobetasol Propionate .5 mg/g 51672-1258-01 | Sun | 1 tube | $0.193 | AB1 | Availability likely | save 77% |
| Clobetasol Propionate .5 mg/g 70700-0109-15 | Xiromed, | 1 tube | $0.193 | AB1 | Availability likely | save 77% |
| Clobetasol Propionate .5 mg/g 62332-0547-15 | Alembic | 1 tube | $0.193 | AB1 | Availability likely | save 77% |
| Clobetasol Propionate .5 mg/g 13668-0569-01 | Torrent | 15 g | $0.193 | AB1 | Availability likely | save 77% |
| Clobetasol Propionate .5 mg/g 00168-0163-15 | E. | 15 g | $0.193 | AB1 | Availability likely | save 77% |
| Clobetasol Propionate .5 mg/g 68180-0956-01 | Lupin | 1 tube | $0.193 | AB1 | Availability likely | save 77% |
| Clobetasol Propionate .5 mg/g 68462-0529-17 | Glenmark | 1 tube | $0.224 | — | FDA listed | save 73% |
| Clobetasol Propionate .5 mg/g 00168-0162-15 | E. | 15 g | $0.295 | AB | FDA listed | save 65% |
| Clobetasol Propionate .5 mg/g 70710-1401-01 | Zydus | 1 tube | $0.329 | AB | FDA listed | save 61% |
| Clobetasol Propionate .5 mg/g 68462-0530-17 | Glenmark | 1 tube | $0.329 | — | FDA listed | save 61% |
| Clobetasol Propionate .5 mg/g 16714-0782-01 | Northstar | 1 tube | $0.329 | — | Discontinued | save 61% |
| Clobetasol Propionate .5 mg/g 51672-1297-01 | Sun | 1 tube | $0.601 | AB2 | Availability likely | save 28% |
| Clobetasol Propionate (emollient) .5 mg/g 83148-0064-15 | The | 1 tube | $0.601 | AB2 | Availability likely | save 28% |
| Clobetasol Propionate .5 mg/g 00168-0293-15 | E. | 15 g | $0.666 | AB | FDA listed | save 21% |
| Clobetasol Propionate (emollient) .5 mg/gthis 00168-0301-30 | E. | 1 tube | $0.839 | AB2 | Discontinued | — |
| Clobetasol Propionate .5 mg/g 45802-0925-14 | Padagis | 1 tube | $0.862 | AB | Availability likely | +3% |
| Clobetasol Propionate .5 mg/g 51672-1294-01 | Sun | 1 tube | $0.862 | AB | Availability likely | +3% |
| Clobetasol Propionate (emollient) .5 mg/g 72162-2628-02 | Bryant | 1 tube | — | AB2 | 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 63629-8637-01 | 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 63629-2331-01 | 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 72162-1438-02 | Bryant | 1 tube | — | AB | FDA listed | — |
| Clobetasol Propionate .5 mg/g 72162-1961-02 | Bryant | 1 tube | — | AB1 | 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 63629-8639-01 | Bryant | 1 tube | — | AB | 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?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Feb 21, 2024
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?
- FDA Orange Book · refreshed Oct 3, 2026
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 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.
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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.
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UNII 2Y53S6ATLU
Dimethicone 350 is a silicone-based oil. It works as a lubricant and anti-foaming agent to help the medicine flow smoothly during manufacturing and reduce unwanted bubbles in the final product.
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UNII M629807ATL
Imidazolidinyl urea is a synthetic preservative that prevents microbial growth in medicines. It's used in formulations to extend shelf life and maintain product safety during storage.
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UNII 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
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UNII YRC528SWUY
A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
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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 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.
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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.
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.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from E. Fougera & Co. a division of Fougera Pharmaceu... labeler code 00168
- Betamethasone Dipropionate .5 mg/mL Lotion, Augmented NDC 0168-0267-30
- Betamethasone Dipropionate .5 mg/g Ointment, Augmented NDC 0168-0268-15
- Clobetasol Propionate .5 mg/mL Solution NDC 0168-0269-50
- Clindamycin Phosphate 20 mg/g Cream NDC 0168-0277-40
- Amcinonide 1 mg/g Cream NDC 0168-0278-15
- Clobetasol Propionate .5 mg/g Gel NDC 0168-0293-15
- Metronidazole 7.5 mg/g Cream NDC 0168-0323-46
- Fluticasone Propionate .5 mg/g Cream NDC 0168-0332-15
- Terconazole 4 mg/g Cream NDC 0168-0346-46
- Terconazole Vaginal Cream 0.8% 8 mg/g Cream NDC 0168-0347-20
- Lidocaine and Prilocaine 25 mg/g; 25 mg/g Cream NDC 0168-0357-30
- Oxiconazole Nitrate 10 mg/g Cream NDC 0168-0358-30
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Clobetasol propionate cream, 0.05% (emollient) is a corticosteroid indicated for: • The relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older. (1.1) • The treatment of moderate to severe plaque-type psoriasis in patients 16 years of age and older. (1.2) Limitations of Use • Clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
(1.3) • The total dosage should not exceed 50 grams per week. (1.3) • Avoid use if skin atrophy is present at the treatment site. (1.3) Clobetasol propionate cream, 0.05% (emollient) is a super-high potency corticosteroid indicated for:
1.1Corticosteroid-Responsive Dermatoses Clobetasol propionate cream, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age and older. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week.
1.2Moderate to Severe Plaque-Type Psoriasis Clobetasol propionate cream, 0.05% (emollient) is indicated for the topical treatment of moderate to severe plaque-type psoriasis. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age is not recommended.
1.3Limitations of Use Clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. The total dosage should not exceed 50 grams per week. Avoid use if skin atrophy is present at the treatment site.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Apply a thin layer of Clobetasol propionate cream, 0.05% (emollient) to the affected skin areas twice daily and rub in gently and completely. Wash hands after each application. Clobetasol propionate cream, 0.05% (emollient) is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used.
In moderate to severe plaque-type psoriasis, Clobetasol propionate cream, 0.05% (emollient) applied to 5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 grams per week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression.
Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended.
Clobetasol propionate cream, 0.05% (emollient) should not be used with occlusive dressings. • Apply a thin layer of Clobetasol propionate cream, 0.05% (emollient) to the affected skin areas twice daily and rub in gently and completely. (2) • Treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used. (2) • In moderate to severe plaque-type psoriasis, Clobetasol propionate cream, 0.05% (emollient) applied to 5% to 10% of body surface area can be used for up to 4 weeks.
The total dosage should not exceed 50 grams per week. When dosing for more than 2 weeks, any additional benefit of extending treatment should be weighed against the risk of HPA suppression. (2)
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Cream, 0.05%. Each gram of Clobetasol propionate cream USP, 0.05% (emollient) contains 0.5 mg of clobetasol propionate in a white to off-white cream base. Cream: 0.05% (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None (4)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis doses as low as 2 grams per day. (5.1) • Cushing's syndrome, hyperglycemia, and glucosuria can also result from systemic absorption of topical corticosteroids. (5.1) • Systemic absorption may require periodic evaluation for HPA axis suppression.
Modify use if HPA axis suppression develops. (5.1) • Children may be more susceptible to systemic toxicity from use of topical corticosteroids. (5.1 , 8.4) • Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate.
These reactions include: folliculitis, acneiform eruptions, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. (5.2)
5.1Effects on the Endocrine System Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 grams per day. Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.
Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. In a study including 12 subjects ages 18 years and older with psoriasis or atopic dermatitis involving at least 30% body surface area (BSA), adrenal suppression was identified in 3 out of 12 subjects (25%) following 1 week of treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.
Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [ see Use in Specific Populations (8.4) ]
5.2Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, hypertrichosis, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.
Clobetasol propionate is not recommended in patients with acne vulgaris, rosacea or perioral dermatitis.
5.3Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed with patch testing. If irritation develops, Clobetasol propionate cream, 0.05% (emollient) should be discontinued and appropriate therapy instituted.
5.4Concomitant Skin Infections If concomitant skin infections are present or develop, an appropriate antifungal o… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS • The most common adverse reaction is burning/stinging (incidence 5%); common adverse reactions (incidence < 2%) are pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, tenderness in the elbow, skin atrophy, and telangiectasia. (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In controlled trials with clobetasol propionate formulations, the following adverse reactions have been reported: burning/stinging, pruritis, irritation, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, tenderness in the elbow, skin atrophy, and telangiectasia.
The incidence of local adverse reactions reported in the trials with Clobetasol propionate cream, 0.05% (emollient) was less than 2% of patients treated with the exception of burning/stinging which occurred in 5% of treated patients.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Therefore, Clobetasol propionate cream, 0.05% (emollient) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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 by this route; 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 0.33 and 0.01 times, respectively, the human topical dose of Clobetasol propionate cream, 0.05% (emollient).
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 0.001 and 0.003 times, respectively, the human topical dose of Clobetasol propionate cream, 0.05% (emollient).
Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.
8.3Females and Males of Reproductive Potential 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 cream, 0.05% (emollient) is administered to a nursing woman.
8.4Pediatric Use Safety and effectiveness of Clobetasol propionate cream, 0.05% (emollient) in pediatric patients have not been established and its use in pediatric patients under 12 years of age is not recommended. In a study including 12 subjects ages 18 years and older with psoriasis or atopic dermatitis involving at least 30% body surface area (BSA), adrenal suppression was identified in 3 out of 12 subjects (25%) following 1 week of treatment. Four-week HPA axis suppression studies with Clobetasol propionate cream, 0.05% (emollient) in pediatric subjects have not been conducted.
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 glucocorticosteroid insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
The use of Clobetasol propionate cream, 0.05% (emollient) for 4 consecutive weeks has not been studied in pediatric patients under 16 years of age.
8.5Geriatric Use Clinical studies of Clobetasol propionate cream, 0.05% (emollient) did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Therefore, Clobetasol propionate cream, 0.05% (emollient) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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 by this route; 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 0.33 and 0.01 times, respectively, the human topical dose of Clobetasol propionate cream, 0.05% (emollient).
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 0.001 and 0.003 times, respectively, the human topical dose of Clobetasol propionate cream, 0.05% (emollient).
Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of Clobetasol propionate cream, 0.05% (emollient) in pediatric patients have not been established and its use in pediatric patients under 12 years of age is not recommended. In a study including 12 subjects ages 18 years and older with psoriasis or atopic dermatitis involving at least 30% body surface area (BSA), adrenal suppression was identified in 3 out of 12 subjects (25%) following 1 week of treatment. Four-week HPA axis suppression studies with Clobetasol propionate cream, 0.05% (emollient) in pediatric subjects have not been conducted.
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 glucocorticosteroid insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
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 absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
The use of Clobetasol propionate cream, 0.05% (emollient) for 4 consecutive weeks has not been studied in pediatric patients under 16 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of Clobetasol propionate cream, 0.05% (emollient) did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
🆘 Overdosage ▾
10 OVERDOSAGE Topically applied Clobetasol propionate cream, 0.05% (emollient) can be absorbed in sufficient amounts to produce systemic effects [ see Warnings and Precautions (5.1) ].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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 .
12.2Pharmacodynamics Clobetasol propionate cream, 0.05% (emollient) is in the super-high range of potency as demonstrated in a vasoconstrictor study in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.
12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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 .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Clobetasol Propionate Cream USP, 0.05% (emollient), is a white to off-white cream, supplied as follows: NDC 0168-0301-15 15 g tube NDC 0168-0301-30 30 g tube NDC 0168-0301-60 60 g tube Storage and Handling Store between 15°C and 30°C (59°F and 86°F) Clobetasol Propionate Cream USP, 0.05% (emollient) should not be refrigerated.
📦 Storage and Handling ▾
Storage and Handling Store between 15°C and 30°C (59°F and 86°F) Clobetasol Propionate Cream USP, 0.05% (emollient) should not be refrigerated.
📋 Description ▾
11 DESCRIPTION Clobetasol propionate cream USP, 0.05% (emollient) contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical 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. Each gram of Clobetasol propionate cream USP, 0.05% (emollient) contains 0.5 mg of clobetasol propionate in a white to off-white cream base consisting of cetostearyl alcohol, isopropyl myristate, propylene glycol, , polyoxyl 20 cetostearyl ether, dimethicone 350, citric acid, sodium citrate, purified water, and imidurea as a preservative. structure.jpeg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Inform patients using topical corticosteroids of the following information and instructions: • Clobetasol propionate cream, 0.05% (emollient) is for external use only. Avoid contact with the eyes. • Use as directed. Do not use Clobetasol propionate cream, 0.05% (emollient) for any disorder other than that for which it was prescribed.
Do not use longer than the prescribed time period. • Do not use other corticosteroid-containing products while using Clobetasol propionate cream, 0.05% (emollient) unless directed by the physician. • The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. • Wash hands after applying the medication. • Report any signs of local or systemic adverse reactions to the physician. • Inform their physicians that they are using Clobetasol propionate cream, 0.05% (emollient) if surgery is contemplated.
If you go to another doctor for illness, injury or surgery, tell the doctor you are using Clobetasol propionate cream, 0.05% (emollient). • Do not use Clobetasol propionate cream, 0.05% (emollient) on the face, underarms or groin areas. • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician. • Use no more than 50 grams per week of Clobetasol propionate cream, 0.05% (emollient). • Store between 59°F and 86° F (15°C and 30°C).
Do not refrigerate.
🍼 Nursing Mothers ▾
8.3Females and Males of Reproductive Potential 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 cream, 0.05% (emollient) is administered to a nursing woman.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Clobetasol propionate cream, 0.05% (emollient) is in the super-high range of potency as demonstrated in a vasoconstrictor study in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES In a controlled clinical trial involving patients with moderate to severe plaque-type psoriasis, Clobetasol propionate cream, 0.05% (emollient) was applied to 5% to 10% of body surface area. In this trial, there were no clobetasol-treated patients with clinically significant decreases in morning cortisol levels after 4 weeks of treatment; however, morning cortisol levels may not identify patients with adrenal dysfunction.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Mutagenesis Clobetasol propionate was nonmutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. Coli B WP2 fluctuation test.
Impairment of Fertility Studies in the rat following oral administration at dosage levels up to 50 mg/kg per day revealed no significant effect on the males. The females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Mutagenesis Clobetasol propionate was nonmutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. Coli B WP2 fluctuation test.
Impairment of Fertility Studies in the rat following oral administration at dosage levels up to 50 mg/kg per day revealed no significant effect on the males. The females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.
📄 Package Label / Principal Display Panel ▾
Package Label - Principal Display Panel – 15g Tube Label NDC 0168-0301-15 CLOBETASOL PROPIONATE CREAM USP, 0.05% (EMOLLIENT) Rx only FOR TOPICAL USE ONLY. NET WT 15 grams 15gtube
Package Label - Principal Display Panel – 15g Tube Carton NDC 0168-0301-15 Rx only CLOBETASOL PROPIONATE CREAM USP, 0.05% (EMOLLIENT) FOR TOPICAL USE ONLY. NET WT 15 grams 15gcarton
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