Label: MYHELPER - 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 May 3, 2012

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    BENZOYL PEROXIDE 5%

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  • PURPOSE

    PURPOSE

    ACNE TREATMENT

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  • INDICATIONS & USAGE

    USE FOR TREATMENT OF ACNE

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  • WARNINGS

    WARNINGS
    FOR EXTERNAL USE ONLY
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  • DO NOT USE

    DO NOT USE

    • IF YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO BENZOYL PEROXIDE.
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  • ASK DOCTOR/PHARMACIST

    ASK A DOCTOR OR PHARMACIST BEFORE USE IF

    • PREGNANT OR LACTATING. 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.
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  • WHEN USING

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER.
    • KEEP AWAY FROM LIPS AND MOUTH.
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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    • IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
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  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • USE 1-3 TIMES DAILY ONTO CLEAN SKIN. TWIST BASE OF PEN UNTIL PRODUCT APPEARS ON BRUSH. GENTLY APPLY TO PROBLEM AREA. DAILY USE OF SUNSCREEN IS RECOMMENDED.
    • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE EVERY OTHER DAY.
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  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    • AVOID STORAGE AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).
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  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: WATER,  POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, ACETYL CARBOXYMETHYL COCOYL GLYCINE, PHENOXYETHANOL, CAPRYLYL GLYCOL, DECYLENE GLYCOL, CARBOMER.

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  • QUESTIONS

    QUESTIONS OR COMMENTS?

    CALL 877.423.1314
    • WWW.LOVEMYBODY.COM
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  • PRINCIPAL DISPLAY PANEL

    MYBODY

    MYHELPER

    ACNE SPOT TREATMENT
    5% BENZOYL PEROXIDE

    .07 FL OZ US / 2 ML
    myHELPER_UNIT CARTON_2012-04-30
    Twist Tube_Cropped
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  • INGREDIENTS AND APPEARANCE
    MYHELPER 
    benzoyl peroxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49520-102
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOYL PEROXIDE 5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ACETYL CARBOXYMETHYL COCOYL GLYCINE (UNII: 3TNX4P92J3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49520-102-52 1 in 1 BOX
    1 NDC:49520-102-22 2 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 04/24/2012
    Labeler - mybody (004460532)
    Registrant - mybody (004460532)
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