JON ARES ACNE CONTROL STEP 1- benzoyl peroxide cream 
DADASHIE ACNE SYSTEM INC

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.

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JON ARES (as PLD) - ACNE CONTROL CREAM - STEP 1 (71748-101)

ACTIVE INGREDIENTS

BENZOYL PEROXIDE  5%

PURPOSE

ACNE TREATMENT

USE:

FOR THE TREATMENT OF ACNE

DIRECTIONS:

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.

LBL_2oz_Jon Ares_Step 1

JON ARES ACNE CONTROL  STEP 1
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71748-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71748-101-1160 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00609/30/2017
Labeler - DADASHIE ACNE SYSTEM INC (032214636)

Revised: 8/2023
Document Id: 02fa01c9-b2df-81e8-e063-6394a90a2f44
Set id: 0b221fdd-47c0-40b8-b14a-8e21fc36844a
Version: 6
Effective Time: 20230815
 
DADASHIE ACNE SYSTEM INC