Label: CLEARX 3 BLEMISH CREME- benzoyl peroxide cream

  • 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 December 27, 2017

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  • ACTIVE INGREDIENT

    BENZOYL PEROXIDE  10%

  • PURPOSE

    ACNE TREATMENT

  • USE:

    FOR THE TREATMENT OF ACNE

  • DIRECTIONS:

    USE ONCE OR TWICE DAILY, MORNING AND NIGHT.

  • WARNINGS:

    FOR EXTERNAL USE ONLY.

  • DO NOT USE

    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 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, C 13-14 ISOPARAFFIN, LAURETH-7, BENZYL ALCOHOL, CAPRYLHYDROXAMIC ACID, GLYCERIN, BENTONITE, TRIETHANOLAMINE.

  • PRINCIPAL DISPLAY PANEL

    fffffClearx Blemish Cream tube 2 oz Final Outlined (3)

  • INGREDIENTS AND APPEARANCE
    CLEARX 3 BLEMISH CREME 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71375-101
    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)  
    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)  
    BENTONITE (UNII: A3N5ZCN45C)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71375-101-1160 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 finalpart333D09/30/2017
    Labeler - CRDG ENTERPRISES INC (080587635)
    Registrant - DADASHIE ACNE SYSTEM INC (032214636)
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