Benzoyl peroxide/hydrocortisone

Dosage Forms & Strengths

benzoyl peroxide/hydrocortisone

topical lotion

• 5%/0.5%

Acne Vulgaris

Apply a thin film to the affected area qDay-TID; massage gently into skin

Dosage Forms & Strengths

benzoyl peroxide/hydrocortisone

topical lotion

• 5%/0.5%

Acne Vulgaris

<12 years: Safety and effectiveness not established

≥12 years: Apply a thin film to the affected area qDay-TID; massage gently into skin

Contraindications

Hypersensitivity to benzoyl peroxide, hydrocortisone or any components

Patients with viral or fungal diseases of the skin

Cautions

For external use only; avoid contact with the eyes, lips, and mouth

May cause suppression of hypothalamic-pituitary-adrenal axis, leading to adrenal crisis in young patients or patients receiving large topical doses for prolonged periods

Discontinue use if irritation, redness, itching, swelling, or undue dryness occurs

Risk of secondary skin infections may increase

Incidence of Kaposi's sarcoma associated with prolonged corticosteroid treatments

Coadministration with other topical acne medications may increase skin irritation and dryness; avoid excessive sun exposure and use sunscreen

Avoid contact with hair and dyed fabrics (eg, pillow cases, towels), which may be bleached by this product

Pregnancy Category: C

Lactation: Excretion in milk unknown; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.