YES TO TOMATOES ROLLER BALL SPOT STICK (SALICYLIC ACID) SOLUTION [AUTUMN HARP, INC.]

YES TO TOMATOES ROLLER BALL SPOT STICK (SALICYLIC ACID) SOLUTION [AUTUMN HARP, INC.]
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NDC 51514-0327-1
Set ID 1abfc187-b7aa-4464-ae6d-2496de96114d
Category HUMAN OTC DRUG LABEL
Packager Autumn Harp, Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
  • WARNINGS AND PRECAUTIONS

    Drug Facts

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses:

    for the treatment of acne

  • Warnings:

    For external use only. Flammable - Keep away from open fire or flame. Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product, as this may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.  When using this product avoid contact with eyes.  If contact occurs, flush thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions:

    Apply Spot Stick directly on blemishes 1 - 3 times daily.  Because excessive drying of skin may occur start with one application and gradually increase as needed. 

  • Inactive Ingredients

    Water, Punica Granatum (Pomegranate) Fruit Juice, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, SD Alcohol 38B, Propanediol, Solanum Lycopersicum (Tomato) Extract*, Aloe Barbadensis Leaf Extract, Chondrus Crispus (Carrageenan) Extract, Lavandula Angustifolia (Lavender) Oil, Citrus Grandis (Grapefruit) Juice, Zingiber Officinale (Ginger) Root Extract*, Bisabolol, Maltodextrin, Glyceryl Caprylate, Sucrose Stearate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Silica, Phenethyl Alcohol, Xanthan Gum, Alcohol. *Certified Organic Ingredient

  • Questions?

    1-888-92-Yes-To (1-888-929-3786) or visit www.yestocarrots.com

  • Principal Display Panel

    Image ComponentsBottle labelUnit Carton label

  • INGREDIENTS AND APPEARANCE
    YES TO TOMATOES ROLLER BALL SPOT STICK 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0327
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.0 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    GRAPEFRUIT JUICE (UNII: JQ9EK2H6BG)  
    PHENETHYL ALCOHOL (UNII: ML9LGA7468)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POMEGRANATE JUICE (UNII: 99S671U9KB)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TOMATO (UNII: Z4KHF2C175)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GINGER (UNII: C5529G5JPQ)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0327-114.7 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/12/2011
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0327)

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