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INDICATIONS AND USAGE

ULTRAVATE (halobetasol propionate) Lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION

Usage: Limit use to 50 g/week. Discontinue treatment when control is achieved. If no improvement is seen within 2 weeks, reassess diagnosis. Treatment beyond 2 consecutive weeks is not recommended. Avoid use on the face, scalp, groin, or axillae.

Effects on Endocrine System: Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. Systemic absorption may require evaluation for HPA axis suppression. Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. Children may be more susceptible to systemic toxicity when treated with topical steroids.

Local Adverse Reactions: Local adverse reactions with topical steroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection and miliaria. These may be more likely to occur with occlusive use, prolonged use or more potent corticosteroids, including ULTRAVATE.

Concomitant Skin Infections: Use an appropriate antimicrobial agent if a skin infection is present or develops.

Allergic Contact Dermatitis: Discontinue ULTRAVATE Lotion if allergic contact dermatitis is established.

In clinical trials the most common adverse reactions (≥1%) were telangiectasia, application site atrophy, and headache.

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.