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

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    BENZOYL PEROXIDE 5%

  • PURPOSE

    PURPOSE

    ACNE TREATMENT

  • INDICATIONS & USAGE

    USE FOR TREATMENT OF ACNE

  • WARNINGS

    WARNINGS
    FOR EXTERNAL USE ONLY
  • DO NOT USE

    DO NOT USE

    • IF YOU HAVE VERY SENSITIVE SKIN OR ARE SENSITIVE TO BENZOYL PEROXIDE.
  • 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.
  • WHEN USING

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER.
    • KEEP AWAY FROM LIPS AND MOUTH.
  • 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.
  • 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.
  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

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

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

  • QUESTIONS

    QUESTIONS OR COMMENTS?

    CALL 877.423.1314
    • WWW.LOVEMYBODY.COM
  • 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
  • INGREDIENTS AND APPEARANCE
    MYHELPER 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49520-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOYL PEROXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49520-102-521 in 1 BOX
    1NDC:49520-102-222 mL in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/24/2012
    Labeler - mybody (004460532)
    Registrant - mybody (004460532)
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