Label: BAREMINERALS BLEMISH THERAPY- sulfur powder

  • 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 February 12, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    SULFUR 3.0%

  • PURPOSE

    ACNE TREATMENT

  • INDICATIONS & USAGE

    USE FOR THE TREATMENT OF ACNE. CLEARS ACNE BLEMISHES AND ALLOWS SKIN TO HEAL. PENETRATES PORES TO CONTROL BLACKHEADS. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

    DO NOT GET INTO EYES.

    IF EXCESSIVE SKIN IRRITATION DEVELOPS OR INCREASES, DISCONTINUE USE AND CONSULT A DOCTOR.

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

  • OTHER INFORMATION

    ADVERSE EVENT REPORTING

    71 STEVENSON ST. 22 FL., SF, CA 94105. ATTN: OTC

  • DIRECTIONS

    SWIRL BRUSH INTO TREATMENT, TAP OFF EXCESS AND GENTLY PAT ONTO BLEMISH. FOR LARGER PROBLEM AREAS, APPLY A LIGHT LAYER OVER AFFECTED AREA (AVOIDING THE EYE AREA). FOR BEST RESULTS, USE AT THE ONSET OF A BLEMISH. APPLYING A LIGHT LAYER OVER PROBLEM AREAS DAILY CAN ALSO HELP PREVENT NEW BREAKOUTS FROM FORMING.

  • INACTIVE INGREDIENTS

    ZINC STEARATE, ILITE, BARIUM SULFATE, SILICA, SALIX ALBA (WILOW) BARK EXTRACT, TAPI OCA STARCH, SOIL MINERALS, KA OLIN, CYCL ODEXTRIN, MELALEUCA ALTERNIF OLIA (TEA TRE) LEAF EXTRACT, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, BETAINE SALICYLATE, CORN STARCH MODIFIED, ALOE BARBADENSIS LEAF JUICE, MELALEUCA ALTERNIF OLIA (TEA TRE) LEAF OIL, EMBLICA OFFICINALIS FRUIT EXTRACT, SOPHORA ANGUSTIFOLIA EXTRACT, ALGAE EXTRACT, RETINOL, DEXTRIN, HYDROXYPR OPYL CYCL ODEXTRIN, MALT ODEXTRIN, FARNE SOL, NIACINAMIDE, MAGNESIUM MYRISTATE, CALCIUM SODIUM PHOSPHOSILICATE, MICA, BISMUTH OXYCHL ORIDE, TITANIUM DIOXIDE.

  • SPL UNCLASSIFIED SECTION

    Dist. by Bare Escentuals Beauty, Inc., SF, CA 94105 USA

  • PRINCIPAL DISPLAY PANEL - 1 g Jar Carton

    bareMinerals

    BLEMISH
    THERAPY

    1 g / 0.03 Oz.

    Principal Display Panel - 1 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    BAREMINERALS BLEMISH THERAPY 
    sulfur powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-725
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC STEARATE (UNII: H92E6QA4FV)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    BETAINE SALICYLATE (UNII: DRF395F9AY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    RETINOL (UNII: G2SH0XKK91)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    FARNESOL (UNII: EB41QIU6JL)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    MICA (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-725-011 in 1 CARTON
    11 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/31/2013
    Labeler - Bare Escentuals Beauty, Inc. (087008363)
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