Label: ST. IVES- salicylic acid soap

  • 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 March 1, 2011

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Use

    Treats Acne

  • Warnings

    For external use only.

    Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a doctor.

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

  • Directions

    Pour onto moistened pouf, sponge or hands. Work into a rich, creamy lather and rinse. Avoid contact with eyes. In case of contact with eyes flush thoroughly with water.

  • Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Camellia Sinensis Leaf Extract, Sodium Chloride, Sodium Hydroxide, Glycerin, Disodium EDTA, Polyquaternium-7, Phenethyl Alcohol, PPG-2 Methyl Ether, Methylisothiazolinone, Fragrance, Green 5, Yellow 5, Red 33, Red 4, Blue 1.

  • Questions?

    1-866-912-9867

  • PRINCIPAL DISPLAY PANEL - 266ml Bottle Label

    NEW!

    St. Ives®

    NATURALLY CLEAR

    BODY WASH
    GREEN TEA

    CLEARS BODY BREAKOUTS
    & REDUCES REDNESS

    OIL-FREE
    salicylic acid acne medication
    with 100% natural green tea

    9 fl oz | 266ml

    Principal Display Panel - 266ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ST. IVES   BODY WASH NATURALLY CLEAR SKIN GREEN TEA
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54726-0600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid0.02 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Glycerin (UNII: PDC6A3C0OX)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Phenylethyl Alcohol (UNII: ML9LGA7468)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    D&C Green No. 5 (UNII: 8J6RDU8L9X)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    FD&C Red No. 4 (UNII: X3W0AM1JLX)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    D&C Red No. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54726-0600-9266 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D02/14/2011
    Labeler - Cosmetic Laboratories of America (617165329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Laboratories of America617165329ANALYSIS, MANUFACTURE
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