O SKIN ACNE MODERATE (BENZOYL PEROXIDE) CREAM [O SKIN CARE LLC]

O SKIN ACNE MODERATE (BENZOYL PEROXIDE) CREAM [O SKIN CARE LLC]
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NDC 71421-101-11
Set ID 03c81f81-8e74-44d5-b23a-5354f5450495
Category HUMAN OTC DRUG LABEL
Packager O SKIN CARE LLC
Generic Name
Product Class
Product Number
Application Number PART333D
  • ACTIVE INGREDIENTS

    BENZOYL PEROXIDE  5%

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  • PURPOSE

    ACNE TREATMENT

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  • USE:

    FOR THE TREATMENT OF ACNE

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  • DIRECTIONS:

    CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT. PAT A THIN LAYER TO AFFECTED AREA DAILY MORNING AND NIGHT AND ALLOW TO DRY.

    • BECAUSE EXCESSIVE DRYING MAY OCCUR, START WITH ONCE DAILY APPLICATION.
    • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO EVERY OTHER DAY.
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  • WARNINGS:

    FOR EXTERNAL USE ONLY.

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  • DO NOT USE

    DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE. THIS PRODUCT MAY CAUSE IRRITATION.

    ASK A PHYSICIAN 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 PHYSICIAN. AVOID UNNECESSARY SUN EXPOSURE. USE A SUNSCREEN WHILE USING THIS PRODUCT AND FOR A WEEK AFTERWARDS.

    STOP USE AND ASK A PHYSICIAN IF SKIN IRRITATION OCCURS, AND BECOMES SEVERE.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • OTHER INFORMATION.

    THIS PRODUCT MAY BLEACH HAIR OR DYE FABRICS. AVOID STORING AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

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  • INACTIVE INGREDIENTS:

    DEIONIZED WATER, PROPYLENE GLYCOL, CARBOMER 940, SODIUM HYDROXIDE, CPE 722.

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  • INGREDIENTS AND APPEARANCE
    O SKIN ACNE  MODERATE
    benzoyl peroxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71421-101
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71421-101-11 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/12/2017
    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(71421-101)
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