Label: ST. IVES GREEN TEA CLEANSER- salicylic acid emulsion

  • 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 8, 2012

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  • ACTIVE INGREDIENT

    Active ingredient
    Salicylic Acid (2%)
  • PURPOSE

    Purpose
    Acne Treatment
  • INDICATIONS & USAGE

    Use
    Treats Acne
  • WARNINGS

    Warnings
    For external use only.

    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.  If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    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 Blemish Control Green Tea Scrub.
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments?
    Visit us at www.stives.com  1-866-912-9867
  • PRINCIPAL DISPLAY PANEL

    PDP
    St. Ives Green Tea Gel Cleanser PDP
  • INGREDIENTS AND APPEARANCE
    ST. IVES  GREEN TEA CLEANSER
    salicylic acid emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1246
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    YEAST (UNII: 3NY3SM6B8U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    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:64942-1246-1200 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/08/2012
    Labeler - CONOPCO Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alberto-Culver USA Inc.021679448manufacture
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