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 January 8, 2010

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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 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

    Wet face. Apply a generous amount of product over face and neck with fingertips. Rinse with water. Use twice daily for best results. Avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Use with Naturally Clear Green Tea Scrub.

  • INACTIVE INGREDIENTS

    Water (Aqua, Eau), Sodium Laureth Sulfate, Glycerin, Cocamidopropyl Betaine, Propylene Glycol, Disodium Laureth Sulfosuccinate, Hydroxyethyl Urea, Camellia Sinensis Leaf Extract1, Olea Europaea (Olive) Leaf Extract, Ascophyllum Nodosum Extract, Alteromonas Ferment Extract, Epilobium Angustifolium Extract, Yeast Extract (Faex, Extrait de Levure), Menthyl Lactate, Fragrance (Parfum), Disodium EDTA, PEG-150 Distearate, Phenethyl Alcohol, Methylisothiazolinone, Sodium Hydroxide, PPG-2 Methyl Ether, Green 5 (CI 61570), Yellow 5 (CI 19140), Red 4 (CI 14700), Red 33 (CI 17200), Blue 1 (CI 42090).

    1
    Green Tea
  • Questions?

    1-888-912-9867

  • PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

    NEW!

    ST. Ives®

    NATURALLY CLEAR

    GREEN TEA CLEANSER

    CLEARS BREAKOUTS & REDUCES REDNESS

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

    6.75 fl oz | 200ml

    PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ST. IVES   NATURALLY CLEAR GREEN TEA FACIAL
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12488-0400
    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)  
    D&C Red No. 33 (UNII: 9DBA0SBB0L)  
    Fd&C Red No. 4 (UNII: X3W0AM1JLX)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    Fd&C Yellow No. 5 (UNII: I753WB2F1M)  
    D&C Green No. 5 (UNII: 8J6RDU8L9X)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)  
    Menthyl Lactate (UNII: 2BF9E65L7I)  
    Glycerin (UNII: PDC6A3C0OX)  
    Phenethyl Alcohol (UNII: ML9LGA7468)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12488-0400-6200 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D01/31/2010
    Labeler - Alberto-Culver USA Inc. (021679448)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alberto-Culver USA Inc.021679448ANALYSIS, MANUFACTURE
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