Label: MYHELPER- benzoyl peroxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49520-102-22, 49520-102-52 - Packager: mybody
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
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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.
- 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
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MYHELPER
benzoyl peroxide creamProduct 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)