JON ARES - ACNE CONTROL CREAM - STEP 2

JON ARES ACNE CONTROL by

Drug Labeling and Warnings

JON ARES ACNE CONTROL by is a Otc medication manufactured, distributed, or labeled by DADASHIE ACNE SYSTEM INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JON ARES ACNE CONTROL STEP 2- 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 - ACNE CONTROL CREAM - STEP 2

ACTIVE INGREDIENTS

BENZOYL PEROXIDE  10%

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.
  • AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH.

WHEN USING THIS PRODUCT

  • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME. IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME.
  • AVOID UNECESSARY SUN EXPOSURE AND USE SUNSCREEN.
  • AVOID CONTACT WITH HAIR AND DYED FBRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT.

  • KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR.
  • DO NOT USE IF YOU HAVE VERY SENSITIVE SKIN OR SENSITIVE TO BENZOYL PEROXIDE.

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

LBL_2oz_Jon Ares_Step 2

JON ARES ACNE CONTROL  STEP 2
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71748-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SULFUR (UNII: 70FD1KFU70)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
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: 71748-102-1160 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/201712/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/30/201712/29/2019
Labeler - DADASHIE ACNE SYSTEM INC (032214636)

Revised: 12/2019
Document Id: 5a6fd14a-4c12-43a4-be7b-833a8e8a6146
Set id: 319f9934-2891-49c4-9195-fff0f97e7238
Version: 2
Effective Time: 20191229
 
DADASHIE ACNE SYSTEM INC