Country: United States
Language: English
Source: NLM (National Library of Medicine)
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)
The Mentholatum Company
TOPICAL
OTC DRUG
Acne treatment treats and helps prevent acne
OTC monograph final
OXY RAPID SPOT TREATMENT MAXIMUM ACTION- BENZOYL PEROXIDE CREAM THE MENTHOLATUM COMPANY _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- DRUG FACTS ACTIVE INGREDIENT Benzoyl peroxide 10% PURPOSE Acne treatment USES treats and helps prevent acne WARNINGS FOR EXTERNAL USE ONLY DO NOT USE IF YOU have very sensitive skin are sensitive to benzoyl peroxide WHEN USING THIS PRODUCT skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using this product less frequently or in a lower concentration. STOP USE AND ASK A DOCTOR IF irritation becomes severe IF PREGNANT OR BREAST-FEEDING Ask a health professional before use. KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS clean skin thoroughly before applying this product cover entire affected area with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor. _Sensitivity Test:_ Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above. INACTIVE INGREDIENTS anhydrous citric acid, buty Read the complete document