Label: ELFMINERAL BLEMISH KIT BOX- 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 November 17, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Sulfur 3.0%

  • PURPOSE

    Purpose:

    Anti Acne

  • INDICATIONS & USAGE

    Uses:

    Heal and disguise blemishes with the all natural Mineral Blemish Kit.  This translucent powder has active acne fighting ingredients like nature sulfur to treat acne and prevent future breakouts while penetrate deep into the pores to control blackheads.

  • WARNINGS

    Warning:

    For external use only

  • WHEN USING

    When Using This Product:

    Do not get into eyes

    Avoid on wounds and on areas of eczema

  • ASK DOCTOR

    Stop Use and Ask A Doctor If:

    Rash or irritation develops and lasts

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children:

    If swallowed get medical help or contact a Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions:

    Take the concealer brush and dap into powder. Apply formula on areas that need spot treatment. Use nightly or daily to treat and prevent future breakouts.

  • STORAGE AND HANDLING

    Other Information:

    Store at room temperature 20-25C (68-77F)

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Zince Stearate, Barium Sulfate, Silica, Kaolin, Dimethicone/Vinyl Dimethicone Crosspolymer, Corn Starch Modified, Alba (Willow) Bark Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Dextrin, Magnesium Myristate, Calcium Sodium Phosphosilicate, Mica, Bismuth Oxychloride, Titanium Dioxide

    May contain:

    Iron Oxides (CI 77491, CI 77492, CI 77499)

  • PRINCIPAL DISPLAY PANEL

    labelabel

  • INGREDIENTS AND APPEARANCE
    ELFMINERAL BLEMISH KIT BOX 
    sulfur powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52664-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC STEARATE (UNII: H92E6QA4FV) 41.4 g  in 100 g
    BARIUM SULFATE (UNII: 25BB7EKE2E) 35.0 g  in 100 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    KAOLIN (UNII: 24H4NWX5CO)  
    WILLOW BARK (UNII: S883J9JDYX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ALFADEX (UNII: Z1LH97KTRM)  
    MICA (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52664-006-013.3 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/01/2010
    Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
    Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Facecare Cosmetics Co., Ltd.545341856manufacture
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