Label: ELF ZIT ZAPPER- salicylic acid liquid

  • 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:

    Salicylic Acid 1.0%

  • PURPOSE

    Purpose:

    Acne

  • INDICATIONS & USAGE

    Uses:

    • Zap zits away with the unique blend of Salicylic Acid, Tea Tree, Witch Hazel, and Camphor
    • The special clear formula helps to fight and prevent  acne,  reduce redness and swelling,  minimize pore size and clear skin
  • WARNINGS

    Warning:

    For external use only

  • WHEN USING

    When Using This Product:

    Do not get into eyes

    Avoid using on wounds or 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:

    Apply directly to blemishes nightly

  • STORAGE AND HANDLING

    Other Information:

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

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Water, Witch Hazel (Hamamelis Virginiana) Distillate, Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Cinnamomum Camphora (Camphor) Bark Oil
  • PRINCIPAL DISPLAY PANEL

    labelabel

  • INGREDIENTS AND APPEARANCE
    ELF ZIT ZAPPER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52664-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 86.70 g  in 100 g
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    ALCOHOL (UNII: 3K9958V90M)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52664-007-016 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/01/2010
    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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