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On Target (CoValence Inc.)

Available Formats

Dosage Form Package Information Links
GEL 30 g in 1 BOTTLE, PLASTIC (66915-437-02) Label Information
GEL 200000 g in 1 DRUM (66915-437-01) Label Information

Complete On Target Information

  • 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.


  • INGREDIENTS AND APPEARANCE
    ON TARGET 
    benzoyl peroxide gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66915-437
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 0.102 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66915-437-01 200000 g in 1 DRUM; Type 0: Not a Combination Product 08/18/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 08/18/2011
    Labeler - CoValence, Inc. (070653204)
    Registrant - CoValence, Inc (070653204)
    Establishment
    Name Address ID/FEI Business Operations
    CoValence, Inc. 070653204 manufacture(66915-437)