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 1%

  • 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 daily for best results. Avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Use with Naturally Clear Green Tea Cleanser.

  • INACTIVE INGREDIENTS

    Inactive Ingredients: Water (Aqua, Eau), Hydrated Silica, Potassium Laureth Phosphate, Glycerin, Sodium Lauroamphoacetate, Sodium Methyl 2-Sulfolaurate, Polyacrylate-1 Crosspolymer, Citric Acid, Glycereth-18 Ethylhexanoate, Kaolin, Disodium 2-Sulfolaurate, Camellia Sinensis Leaf Extract, Epilobium Angustifolium Extract, Olea Europaea (Olive) Leaf Extract, Ascophyllum Nodosum Extract, Alteromonas Ferment Extract, Yeast Extract (Faex, Extrait de Levure), Hydrolyzed Jojoba Esters, PPG-2 Methyl Ether, Fragrance (Parfum), Glycereth-18, Phenethyl Alcohol, Methylisothiazolinone, Yellow 5 (CI 19140), Red 4 (CI 14700), Red 33 (CI 17200), Blue 1 (CI 42090).

  • Questions?

    1-888-912-9867

  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Label

    NEW!

    ST. Ives®

    NATURALLY CLEAR

    GREEN TEA SCRUB

    CLEARS BREAKOUTS & REDUCES REDNESS

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

    4.5 fl oz | 133ml

    PRINCIPAL DISPLAY PANEL - 133 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:12488-0300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid0.01 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)  
    Kaolin (UNII: 24H4NWX5CO)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Phenethyl Alcohol (UNII: ML9LGA7468)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12488-0300-4133 mL in 1 TUBE
    2NDC:12488-0300-128 mL in 1 TUBE
    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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