Drugplain

Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g

Clobetasol Propionate Cream USP, 0.05% · CREAM · Encube Ethicals, Inc.

No Recall History
Plain English

Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% is a cream containing clobetasol propionate cream usp, 0.05% at .5 mg/g, taken topical. Manufactured by Encube Ethicals, Inc..

Key Facts

Brand Name
Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%
Generic Name
Clobetasol Propionate Cream USP, 0.05%
NDC Code (Product)
21922-016
Manufacturer
Encube Ethicals, Inc.
Strength
.5 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA212982
Marketing Start
10/01/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective26 reports
pruritus9 reports
product use issue8 reports
application site pain7 reports
inappropriate schedule of drug administration6 reports
burning sensation5 reports
dry skin5 reports
application site discolouration4 reports
drug effect incomplete4 reports
erythema4 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE: Clobetasol propionate cream USP, 0.05% 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 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. 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 & Administration

DOSAGE AND ADMINISTRATION: Apply a thin layer of clobetasol propionate cream 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% is 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 Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% used for?

Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% contains Clobetasol Propionate Cream USP, 0.05%. It is a cream taken topical. Consult your doctor for specific uses.

Is Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% a controlled substance?

Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% is not classified as a controlled substance by the DEA.

What is the generic name for Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05%?

The generic name for Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% is Clobetasol Propionate Cream USP, 0.05%. There are no other listed brand versions of Clobetasol Propionate Cream USP, 0.05%.

What is the NDC code for Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g?

The NDC (National Drug Code) for Clobetasol Propionate Cream USP, 0.05% Clobetasol Propionate Cream USP, 0.05% .5 mg/g is 21922-016, listed by Encube Ethicals, Inc..

Product NDC

21922-016

Package NDC

21922-016-04

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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