JON ARES ACNE CONTROL MILD- resorcinil, sulfur 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 - MILD (71748-103)

ACTIVE INGREDIENTS

RESORCINOL 2%

SULFUR 6%

PURPOSE

ACNE TREATMENT

USE:

FOR THE TREATMENT OF ACNE

DIRECTIONS:

WARNINGS:

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.

WHEN USING THIS PRODUCT

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A 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, C 13-14 ISOPARAFFIN, LAURETH-7, BENZYL ALCOHOL, CAPRYLHYDROXAMIC ACID, GLYCERIN, ZINC OXIDE.

LBL_2oz_Jon Ares_Mild

JON ARES ACNE CONTROL  MILD
resorcinil, sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71748-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL2 g  in 100 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 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)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71748-103-1160 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: 02f9ed76-5e0a-348b-e063-6394a90aa122
Set id: ca3e55ae-2847-4619-a881-9417db2e83ac
Version: 3
Effective Time: 20230815
 
DADASHIE ACNE SYSTEM INC