Country: United States
Language: English
Source: NLM (National Library of Medicine)
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)
CoValence, Inc.
BENZOYL PEROXIDE
BENZOYL PEROXIDE 0.102 g in 1 g
TOPICAL
OTC DRUG
OTC monograph final
ON TARGET- BENZOYL PEROXIDE GEL COVALENCE, INC. _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._ ---------- OTC DRUG FACTS ON TARGET BPO CLEANSER PRINCIPAL DISPLAY PANEL ACTIVE INGREDIENTS: Benzoyl Peroxide 10% PURPOS E: Acne Treatment WARNINGS : Children under 12 years of age: Do not use, consult a physician. WARNINGS : For external use only. Avoide contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in blaching or discoloration. If exceessive irritation develops, disconintue use and consult your physician. DIRECTIONS : Adults and children 12 years of age or older: Apply to the affected are no more than 3 to 4 times daily. INGREDIENTS : Cocamidopropyl Betain, Aqua (Water), Sodium Coco-Glucoside Tartrate, Decyl Glucoside, Sodium Lauroyl Lactylate, Polyacrylate-1 Crosspolymer, Sodium Methyl Cocoyl Taurate, Hydroxypropyl Methylcellulose, Cymbopogon Schoenathus (Lemongrass) Oil*, Magnesium Aluminum Silicate, Glycolid Acid, Hamamelis Virginiana (Witch Hazel) Water, Caprylyl Glycol, 1,2-Hexanediol, Potassium Sorbate, Citric Acid, Alcohol, Tropolone *Certified Organic US ES : Antibacterial cleanser for the treatment of acne and acne prone skin. ON TARGET benzoyl peroxide gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 6 9 15-437 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH BENZO YL PERO XIDE (UNII: W9 WZN9 A0 GM) (BENZOYL PEROXIDE - UNII:W9 WZN9 A0 GM) BENZOYL PEROXIDE 0 .10 2 g in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH DECYL GLUCO SIDE (UNII: Z17H9 7EA6 Y) 1 g in 1 g WA TER (UNII: 0 59 QF0 KO0 R) 1 g in 1 g SO DIUM LAURO YL LACTYLATE (UNII: 7243K8 5WFO) 1 g in 1 g SO DIUM METHYL CO CO YL TAURATE (UNII: JVL9 8 CG53G) 1 g in 1 g WITCH Read the complete document