Label: SKIN CLEARIFY MASK- 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 October 10, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid (0.6%)

  • PURPOSE

    Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Uses

    For the treatment of acne. Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads.

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Use Clearify Cleanser before applying this product. Apply a thin layer and leave on for up to 10 minutes. Rinse thoroughly with warm water. Use up to 3 times a week or as needed. Follow with Clearify Moisturizer.
    • If bothersome dryness or peeling occurs, reduce application to once a week and gradually increase to two to three times per week.
  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Kaolin, Butylene Glycol, Bentonite, Montmorillonite, Cetearyl Alcohol, Titanium Dioxide, Magnesium Aluminum Silicate, Cocamidopropyl Betaine, Salix Alba (Willow) Bark Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Glycerin, Xanthan Gum, Triethanolamine, Disodium EDTA, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Phenoxyethanol.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Herbalife International of America, Inc.

    800 W. Olympic Blvd., Suite 406, Los Angeles, CA 90015 USA

    Made in USA with US and imported ingredients.

    © 2016 HERBALIFE

  • PRINCIPAL DISPLAY PANEL

    HERBALIFE

    SKIN Clearify

    Mask

    Salicylic Acid Acne Treatment

    4 fl oz (120 ml)

    01_Mask

  • INGREDIENTS AND APPEARANCE
    SKIN CLEARIFY MASK 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51785-816
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    KAOLIN (UNII: 24H4NWX5CO)  
    BENTONITE (UNII: A3N5ZCN45C)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    MONTMORILLONITE (UNII: A585MN1H2L)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51785-816-001 in 1 CARTON10/01/2016
    1120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2016
    Labeler - Herbalife International of America Inc. (873035968)
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