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JON ARES ACNE CONTROL STEP 1

Medically reviewed on December 29, 2017

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 5g in 100mL
Labeler: DADASHIE ACNE SYSTEM INC
NDC Code: 71748-101

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.

JON ARES - ACNE CONTROL CREAM - STEP 1

ACTIVE INGREDIENTS

BENZOYL PEROXIDE  5%

PURPOSE

ACNE TREATMENT

USE:

FOR THE TREATMENT OF ACNE

DIRECTIONS:
  • CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT.
  • COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY. BECAUSE OF EXCESS DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A PHYSICIAN.
  • IF BOTHERSOME DRYNESS, REDNESS, ITCHING OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY. STOP USE AND ASK A PHYSICIAN IF IRRITATION BECOMES SEVERE.
  • IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USE OF BOTH PRODUCTS AND ASK A PHYSICIAN.

WARNINGS:

FOR EXTERNAL USE ONLY.

DO NOT USE THIS PRODUCT IF YOU HAVE VERY SENSITIVE SKIN OR IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE. THIS PRODUCT MAY CAUSE IRRITATION.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF 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. AVOID UNNECESSARY SUN EXPOSURE. USE A SUNSCREEN, WHILE USING THIS PRODUCT AND FOR A WEEK AFTERWARDS.

STOP USE AND ASK A DOCTOR IF SKIN IRRITATION OCCURS, AND BECOMES SEVERE.

KEEP OUT OF REACH OF CHILDREN. KEEP AWAY FROM LIPS AND MOUTH. IF SWALLOWED, GET MEDICAL HELP OR CONTACT THE POISON CONTROL CENTER RIGHT AWAY.

OTHER INFORMATION.

THIS PRODUCT MAY BLEACH HAIR OR DYE FABRICS. AVOID STORING AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).

INACTIVE INGREDIENTS:

WATER, PROPYLENE GLYCOL, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, BENZYL ALCOHOL, CAPRYLHYDROXIC ACID, GLYCERIN.

JON ARES ACNE CONTROL  STEP 1
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71748-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
POLYACRYLAMIDE (1500 MW) 
C13-14 ISOPARAFFIN 
LAURETH-7 
BENZYL ALCOHOL 
CAPRYLHYDROXAMIC ACID 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:71748-101-1160 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/30/2017
Labeler - DADASHIE ACNE SYSTEM INC (032214636)

 
DADASHIE ACNE SYSTEM INC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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