Myhelper
FDA Label NDC 49520-102

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mybody for the product Myhelper (NDC 49520-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT

BENZOYL PEROXIDE 5%

Otc - Purpose

PURPOSE

ACNE TREATMENT

Indications & Usage

USE FOR TREATMENT OF ACNE

Warnings

WARNINGSFOR EXTERNAL USE ONLY

Otc - Do Not Use

DO NOT USE

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

Otc - 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.

Otc - When Using

WHEN USING THIS PRODUCT

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

Otc - 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.

Otc - Questions

QUESTIONS OR COMMENTS?

CALL 877.423.1314
  • WWW.LOVEMYBODY.COM

Package Label.Principal Display Panel

MYBODY

MYHELPER

ACNE SPOT TREATMENT
5% BENZOYL PEROXIDE

.07 FL OZ US / 2 ML

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