Label: ST. IVES BLACKHEAD CLEARING GREEN TEA SCRUB- 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 November 6, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient
    Salicylic Acid (1%)

  • PURPOSE

    Purpose
    Acne Treatment

  • INDICATIONS & USAGE

    Uses
    · For the treatment of acne

    · Helps prevent new blackheads and acne blemishes from forming

  • 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  · Clean the skin thoroughly before applying this product. · Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily. · Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.  · If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    ​​​​

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water (Aqua), Hydrated Silica, Glycerin, Glyceryl Stearate SE, Sodium Lauryl Sulfoacetate, Cocamidopropyl Betaine, Cetearyl Alcohol, Cetyl Alcohol, Triethanolamine, PEG-100 Stearate, Cetyl Acetate, Glyceryl Stearate, Fragrance (Parfum), Polysorbate 60, Ceteareth-20, Carbomer, Acetylated Lanolin Alcohol, PPG-2 Methyl Ether, Phenethyl Alcohol, Methylisothiazolinone, Olea Europaea (Olive) Leaf Extract, Camellia Sinensis Leaf Extract, Blue 1 (CI 42090), Red 4 (CI 14700), Red 33 (CI 17200), Yellow 5 (CI 19140).

  • QUESTIONS

    Questions or Comments?

    USA: 1-866-912-9867

  • 6 oz PDP

    StIvesBlackheadClearingGreenTeaScrubPDP

  • INGREDIENTS AND APPEARANCE
    ST. IVES  BLACKHEAD CLEARING GREEN TEA SCRUB
    salicylic acid emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1336
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid0.01 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
    PPG-2 METHYL ETHER (UNII: RQ1X8FMQ9N)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1336-1170 mL in 1 TUBE
    2NDC:64942-1336-228 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2014
    Labeler - CONOPCO Inc. d/b/a Unilever (001375088)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unilever Manufacturing (US), Inc.021679448manufacture(64942-1336)