Label: YES TO TOMATOES ACNE CONTROL GEL CLEANSER- salicylic acid gel

  • 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 6, 2014

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  • WARNINGS AND PRECAUTIONS

    Drug Facts

  • Active Ingredients

    Salicylic Acid 1%

  • Purpose

    Acne Treatment

  • Uses:

    for the treatment of acne

  • 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. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions:

    Clean the skin thoroughly before applying this product · cover the entire affected area with a thin layer 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 Ingredients

    Water, Lauryl Glucoside, Cocamidopropyl Betaine, Propanediol, Glycerin, Sodium Chloride, Aloe Barbadensis Leaf Extract*, Solanum Lycopersicum (Tomato) Extract*, Phenethyl Alcohol, Glyceryl Caprylate, Citric Acid, Alcohol, Fragrance. *Certified Organic Ingredient 

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  • INGREDIENTS AND APPEARANCE
    YES TO TOMATOES ACNE CONTROL GEL CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0329
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    glycerin (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENETHYL ALCOHOL (UNII: ML9LGA7468)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    TOMATO (UNII: Z4KHF2C175)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    COUMARIN (UNII: A4VZ22K1WT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0329-1155 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/27/2011
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0329)
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