OTC Medication Information: MyHELPER

MYHELPER — benzoyl peroxide cream
mybody

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.

ACTIVE INGREDIENT

BENZOYL PEROXIDE 5%

PURPOSE

ACNE TREATMENT

USE FOR TREATMENT OF ACNE

WARNINGS
FOR EXTERNAL USE ONLY

DO NOT USE

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

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 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

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

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 INFORMATION

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

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

QUESTIONS OR COMMENTS?


  • WWW.LOVEMYBODY.COM

MYBODY

MYHELPER


5% BENZOYL PEROXIDE
.07 FL OZ US / 2 ML
myHELPER_UNIT CARTON_2012-04-30
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Twist Tube_Cropped
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MYHELPER benzoyl peroxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49520-102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOIC ACID) BENZOYL PEROXIDE 5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
POLYACRYLAMIDE (1500 MW)
C13-14 ISOPARAFFIN
LAURETH-7
ACETYL CARBOXYMETHYL COCOYL GLYCINE
PHENOXYETHANOL
CAPRYLYL GLYCOL
DECYLENE GLYCOL
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49520-102-52 1 APPLICATOR (APPLICATOR) in 1 BOX contains a APPLICATOR (49520-102-22)
1 NDC:49520-102-22 2 mL in 1 APPLICATOR This package is contained within the BOX (49520-102-52)
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)

Revised: 05/2012 mybody

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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