clobetasol propionate emollient formulation

Product Type: HUMAN PRESCRIPTION DRUG

Route: TOPICAL

Dosage Form:

NDC: 45802-637

Application: ANDA201402

Effective: 20220331

1 INDICATIONS AND USAGE Clobetasol Propionate Foam, 0.05% (Emulsion) is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. • Clobetasol Propionate Foam, 0.05% (Emulsion) is a corticosteroid indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. ( 1 )

2 DOSAGE AND ADMINISTRATION • Apply a thin layer of Clobetasol Propionate Foam, 0.05% (Emulsion) to the affected area(s) twice daily, morning and evening, for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. • The maximum weekly dose should not exceed 50 g or an amount greater than 21 capfuls per week. • For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. • Dispense a small amount of foam (about a capful) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed. • Clobetasol Propionate Foam, 0.05% (Emulsion) is not for oral, ophthalmic, or intravaginal use. • Avoid contact with the eyes. • Avoid use on face, axillae, and groin, or if skin atrophy is present at the treatment site. • Wash hands after each application. Clobetasol Propionate Foam, 0.05% (Emulsion) is not for oral, ophthalmic, or intravaginal use ( 2 ). • Apply Clobetasol Propionate Foam, 0.05% (Emulsion) to the affected area(s) twice daily, morning and evening, for up to 2 consecutive weeks. The maximum weekly dose should not exceed 50 g. ( 2 ) • Avoid use on face, axilla, and groin, or if skin atrophy is present at the treatment site. ( 2 )

4 CONTRAINDICATIONS None. None. ( 4 )

Not available.

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Effects on Endocrine System [see Warnings and Precautions (5.1)] • Ophthalmic Adverse Reactions [see Warnings and Precautions (5.3)] • The most common adverse reactions (incidence ≥ 1%) are application site atrophy and application site reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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 clinical trials involving 821 subjects exposed to clobetasol propionate foam, 0.05% (emulsion) and vehicle foam, the pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with clobetasol propionate foam, 0.05% (emulsion) was 1.9% for application site atrophy and 1.6% for application site reaction. Most local adverse events were rated as mild to moderate and they were not affected by age, race, or gender. 6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post-approval use of clobetasol formulations: erythema, pruritus, burning, alopecia, and dryness. The following additional local adverse reactions have been reported with topical corticosteroids: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, such as clobetasol propionate. Cushing’s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. Ophthalmic adverse reactions may include cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy.