O SKIN ACNE BENZOYL WASH (BENZOYL PEROXIDE) LOTION [O SKIN CARE LLC]

O SKIN ACNE BENZOYL WASH (BENZOYL PEROXIDE) LOTION [O SKIN CARE LLC]
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NDC 71421-102-11
Set ID 3f8c82a5-774b-4c5e-9648-8063e00ac671
Category HUMAN OTC DRUG LABEL
Packager O SKIN CARE LLC
Generic Name
Product Class
Product Number
Application Number PART333D
  • ACTIVE INGREDIENTS

    BENZOYL PEROXIDE  2.5%

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  • PURPOSE

    ACNE TREATMENT

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  • USE:

    FOR THE TREATMENT OF ACNE

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  • DIRECTIONS:

    WET FACE. SQUEEZE A SMALL AMOUNT (DIME SIZE) INTO HANDS. APPLY TO FACE. GENTLY MASSAGE FOR 20 SECONDS. RINSE THOROUGHLY. USE MORNING AND NIGHT. IF BOTHERSOME DRYNESS, REDNESS, ITCHING OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. STOP USE AND ASK A PHYSICIAN IF IRRITATION IS SEVERE.

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  • WARNINGS:

    FOR EXTERNAL USE ONLY.

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  • DO NOT USE

    DO NOT USE THIS MEDICATION IF YOU ARE ALLERGIC TO BENZOYL PEROXIDE OR HAVE SENSITIVE SKIN.

    ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR. DISCONTINUE USE IF SKIN IRRITATION OCCURS.

    WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. AVOID UNNECESSARY SUN EXPOSURE. USE A SUNSCREEN, WHILE USING THIS PRODUCT AND FOR A WEEK AFTERWARDS. THIS PRODUCT MAY BLEACH HAIR AND FABRIC.

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT THE POISON CONTROL CENTER RIGHT AWAY.

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  • INACTIVE INGREDIENTS:

    WATER, SODIUM METHYL-2 SULFOLAURATE, COCAMIDOPROPYL HYDROXYSULTAINE, SODIUM LAURYL SULFOACETATE, COCAMIDOPROPYL BETAINE, DISODIUM 2-SULFOLAURATE, DECYLGLUCOSIDE POLYETHYLENE, SOYAMIDOPROPYL-DIMETHYLAMINE OXIDE, CAPRYLHYDROXAMIC ACID, PHENETHYL ALCOHOL, GLYCERIN

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  • INGREDIENTS AND APPEARANCE
    O SKIN ACNE BENZOYL WASH 
    benzoyl peroxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71421-102
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71421-102-11 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/14/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 05/01/2017
    Labeler - O SKIN CARE LLC (021275401)
    Establishment
    Name Address ID/FEI Business Operations
    PRIVATE LABEL PARTNERS 046033481 manufacture(71421-102)
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