Label: JON ARES ACNE CONTROL STEP 2- benzoyl peroxide cream

  • NDC Code(s): 71748-102-11
  • Packager: DADASHIE ACNE SYSTEM INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 15, 2023

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  • 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 OUT OF REACH OF CHILDREN

    • 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

    • 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.

  • PRINCIPAL DISPLAY PANEL

    LBL_2oz_Jon Ares_Step 2

  • INGREDIENTS AND APPEARANCE
    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 Product09/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00609/30/2017
    Labeler - DADASHIE ACNE SYSTEM INC (032214636)
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