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.

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OTC Drug Facts On Target BPO Cleanser

Principal Display Panel

Label

Active Ingredients:

Benzoyl Peroxide 10%

Purpose:

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

Uses:

Antibacterial cleanser for the treatment of acne and acne prone skin.

ON TARGET 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-437
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.102 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 1 g  in 1 g
Water (UNII: 059QF0KO0R) 1 g  in 1 g
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) 1 g  in 1 g
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) 1 g  in 1 g
WITCH HAZEL (UNII: 101I4J0U34) 1 g  in 1 g
1,2-HEXANEDIOL (UNII: TR046Y3K1G) 1 g  in 1 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1 g  in 1 g
CYMBOPOGON SCHOENANTHUS LEAF (UNII: XF54B1Z2HF) 1 g  in 1 g
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) 1 g  in 1 g
GLYCOLIC ACID (UNII: 0WT12SX38S) 1 g  in 1 g
CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1 g  in 1 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 1 g  in 1 g
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1 g  in 1 g
ALCOHOL (UNII: 3K9958V90M) 1 g  in 1 g
TROPOLONE (UNII: 7L6DL16P1T) 1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66915-437-01200000 g in 1 DRUM; Type 0: Not a Combination Product08/18/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/18/2011
Labeler - CoValence, Inc. (070653204)
Registrant - CoValence, Inc (070653204)
Establishment
NameAddressID/FEIBusiness Operations
CoValence, Inc.070653204manufacture(66915-437)

Revised: 4/2015
Document Id: 142f5d49-2e3c-4ed1-e054-00144ff8d46c
Set id: d3c6b761-57d5-4a5d-bc78-fecd441a469c
Version: 4
Effective Time: 20150420
 
CoValence, Inc.