Label: O SKIN ACNE MODERATE- benzoyl peroxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 16, 2022

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  • ACTIVE INGREDIENTS

    BENZOYL PEROXIDE  5%

  • PURPOSE

    ACNE TREATMENT

  • USE:

    FOR THE TREATMENT OF ACNE

  • 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.
  • WARNINGS:

    FOR EXTERNAL USE ONLY.

  • 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.

  • 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.

  • OTHER INFORMATION.

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

  • INACTIVE INGREDIENTS:

    DEIONIZED WATER, PROPYLENE GLYCOL, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, BENZYL ALCOHOL, CAPRYLHYDROXAMIC ACID, GLYCRIN

  • PRINCIPAL DISPLAY PANEL

    01b LBL_O Skin_Acne Cream Moderate

  • INGREDIENTS AND APPEARANCE
    O SKIN ACNE  MODERATE
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71421-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71421-101-1160 mL in 1 BOTTLE; Type 0: Not a Combination Product09/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/01/2017
    Labeler - O SKIN CARE LLC (021275401)
    Registrant - O SKIN CARE LLC (021275401)
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