Label: ANTI ACNE EXFOLIATING CLEANSING PADS- salicylic acid swab

  • 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 September 28, 2011

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  • ACTIVE INGREDIENT

    Active ingredient
    Salicylic Acid 1%

    Purpose
    Acne Treatment

    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. This may increase dryness or irritation
    of the skin. If this occurs, only one medication
    should be used unless directed by a doctor.

    Use for the treatment of acne.

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

    Directions After cleansing, sweep pad
    gently over face and neck.

    Inactive ingredients
    Water, SD Alcohol 39-C, Hamamelis Virginiana (Witch
    Hazel) Bark/Leaf/Twig Extract, Sodium Lactate,
    PPG-5-Ceteth-20, PEG-12 Dimethicone, Fragrance
    (Parfum), Linalool, Allantoin, Butylene Glycol, Lysine
    Carboxymethyl Cysteinate, Propylene Glycol, Menthol,
    Poterium Officinale Extract, Cinnamomum Cassia
    Bark Extract, Zingiber Officinale (Ginger) Root Extract,
    Palmaria Palmata Extract, Crithmum Maritimum
    Extract, Himanthalia Elongata Extract, Gigartina
    Stellata Extract, Macrocystis Pyrifera Extract, Sea
    Salt (Maris Sal), Blue 1 (CI 42090), Yellow 5 (CI 19140)

  • PRINCIPAL DISPLAY PANEL

    Image of label aaep242.jpg
    Image of label
  • INGREDIENTS AND APPEARANCE
    ANTI ACNE EXFOLIATING CLEANSING PADS 
    salicylic acid swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-242
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid10 uL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOCYSTEINE LYSINE (UNII: 1D1Y95PXXA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MENTHOL (UNII: L7T10EIP3A)  
    SANGUISORBA MINOR ROOT (UNII: 11YGU8I0TT)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    GINGER (UNII: C5529G5JPQ)  
    DULSE (UNII: 7832HOY4ZQ)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    HIMANTHALIA ELONGATA (UNII: 21RND18XRR)  
    MASTOCARPUS STELLATUS (UNII: 6T087FC66H)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    SEA SALT (UNII: 87GE52P74G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65903-242-0157 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/01/2008
    Labeler - H2O Plus (807722947)
    Registrant - H2O Plus (807722947)
    Establishment
    NameAddressID/FEIBusiness Operations
    H2O Plus807722947manufacture
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