Country: United States
Language: English
Source: NLM (National Library of Medicine)
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
TOPICAL
OTC DRUG
Acne Treatment For the treatment of acne.
OTC monograph final
L-TOPICAL BENZOYL PEROXIDE 10%- BENZOYL PEROXIDE LOTION GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED _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._ ---------- L-TOPICAL BENZOYL PEROXIDE 10% LOTION DRUG FACTS ACTIVE INGREDIENT Benzoyl Peroxide 10% PURPOSE Acne Treatment USE For the treatment of acne. WARNINGS For external use only 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 1 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 or 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 the product less frequently or in a lower concentration. DO NOT USE if you have very sensitive skin or sensitive to benzoyl peroxide. STOP USE Stop use and ask a doctor if irritation or sensitivity develops. KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. OTHER INFORMATION Keep tightly closed. Protect from excessive heat (40° / 140° F) and protect from freezing DIRECTIONS Important to use on a clean face. Cover the affected area with a thin layer 1 to 3 times per day. Because of excessive drying of the skin may occur, start with 1 application per day then gradually increase to 2 applications per day 1 morning and one evening if needed, or as directed by a doctor. If dryness or peeling occurs, reduce use to once a day or once every other day. If going outside, use a sunscreen. If irritation or sensitivity develops stop using both products and ask a doctor. INACTIVE INGREDIENTS Water (Aqua), Glycerin, Propylen Read the complete document