Label: ANTI ACNE CALMING CORRECTOR- 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 September 28, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient
    Salicylic Acid 1.5%

     Purpose
    acne treatment

    Warnings
    For external use only.

    Ask a doctor of 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
    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, rinse
    thoroughly with water.

    Keep out of reach of children. If
    swallowed, get medical help or contact
    a Poison Control Center right away. If
    excessive skin irritation develops or
    increases, discontinue use and consult
    a doctor.

    Directions
    Cleanse the skin thoroughly before
    applying medication. • 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 (Aqua), SD Alcohol 40-B, Hamamelis
    Virginiana (Witch Hazel) Bark/Leaf/Twig
    Extract, Butylene Glycol, Glycerin, Glycolic
    Acid, Sodium Lactate, Linoleamidopropyl
    PG-Dimonium Chloride Phosphate,
    Hydroxyethylcellulose, Sodium Hydroxide,
    Fragrance (Parfum), Polysorbate 20,
    Polyquaternium-10, Hydrolyzed Algin,
    Linalool, Propylene Glycol, Sea Salt (Maris
    Sal), Palmaria Palmata Extract, Crithmum
    Maritimum Extract, Himanthalia Elongata
    Extract, Gigartina Stellata Extract,
    Macrocystis Pyrifera Extract, Zinc Sulfate

    Questions? call 1-800-242-2284
    M-F, 8am-6pm CST

  • PRINCIPAL DISPLAY PANEL

    picture of carton label aacc272.jpgPicture of carton label

  • INGREDIENTS AND APPEARANCE
    ANTI ACNE CALMING CORRECTOR 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-272
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid15 uL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SEA SALT (UNII: 87GE52P74G)  
    DULSE (UNII: 7832HOY4ZQ)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    HIMANTHALIA ELONGATA (UNII: 21RND18XRR)  
    MASTOCARPUS STELLATUS (UNII: 6T087FC66H)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65903-272-021 in 1 CARTON
    1NDC:65903-272-0125 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/01/2010
    Labeler - H2O Plus (807722947)
    Registrant - H2O Plus (807722947)
    Establishment
    NameAddressID/FEIBusiness Operations
    H2O Plus807722947manufacture