Label: ST. IVES NATURALLY CLEAR SKIN GREEN TEA FACIAL- 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 May 6, 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 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.

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

  • Directions

    Moisten face with water. Dispense product onto fingertips and massage over face. Rinse with water. Avoid direct contact with eyes. In case of contact with eyes, flush thoroughly with water.

  • INACTIVE INGREDIENTS

    Water, Glycerin, Stearic Acid, Sodium C14-16 Olefin Sulfonate, Propylene Glycol, Glycereth-18 Ethylhexanoate, Cocamidopropyl Betaine, PEG-100 Stearate, Glyceryl Stearate, Acrylates/Aminoacrylates/C10-30 Alkyl PEG-20 Itaconate Copolymer, Camellia Sinensis Leaf Extract+, Glycereth-18, Sodium Hydroxide, Betaine, Isopropyl Alcohol, Trideceth-50, PPG-2 Methyl Ether, Phenethyl Alcohol, Methylisothiazolinone, Fragrance, Green 5, Yellow 5, Red 33, Red 4, Blue 1.

  • Questions?

    1-866-912-9867

  • PRINCIPAL DISPLAY PANEL - 170 g Tube Label

    ST. Ives®
    FRESH. BETTER. NATURALLY.™

    Naturally Clear

    CREAM CLEANSER

    Green Tea

    Oil-free salicylic acid acne medication
    with 100% natural green tea

    CLEARS BREAKOUTS
    REDUCES REDNESS

    100%
    NATURAL EXTRACTS

    Sulfate
    Free

    Formulated
    without
    Parabens

    Net Wt. 6 OZ | 170g

    Principal Display Panel - 170 g Tube Label
  • INGREDIENTS AND APPEARANCE
    ST. IVES   NATURALLY CLEAR SKIN GREEN TEA FACIAL
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12488-0700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Betaine (UNII: 3SCV180C9W)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Phenylethyl Alcohol (UNII: ML9LGA7468)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    D&C Green No. 5 (UNII: 8J6RDU8L9X)  
    Fd&C Yellow No. 5 (UNII: I753WB2F1M)  
    D&C Red No. 33 (UNII: 9DBA0SBB0L)  
    Fd&C Red No. 4 (UNII: X3W0AM1JLX)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12488-0700-6170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D01/01/2012
    Labeler - Alberto-Culver USA Inc. (021679448)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alberto-Culver USA Inc.021679448ANALYSIS, MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Laboratories of America617165329ANALYSIS, MANUFACTURE
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