Label: ANTI ACNE CLARIFYING FACE WASH- 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

    For external use only

    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 skin. If this occurs, only
    one medication should be used unless directed by a doctor.


    Wash affected area twice daily

    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

    Wash affected area twice daily

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

    Water (Aqua), Sodium C14-16 Olefin Sulfonate,
    Cocamidopropyl Betaine, Glycerin, Sodium Chloride,
    Linoleamidopropyl PG-Dimonium Chloride Phosphate,
    Fragrance (Parfum), Disodium EDTA, Butylene Glycol,
    Aloe Barbadensis Leaf Juice, Menthol, Propylene
    Glycol, Poterium Officinale Root 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, Blue 1 (CI 42090)

  • PRINCIPAL DISPLAY PANEL

    Image of label aacf247.jpg
    Image of label
  • INGREDIENTS AND APPEARANCE
    ANTI ACNE CLARIFYING FACE WASH 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-247
    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)  
    SODIUM C12-14 OLEFIN SULFONATE (UNII: 7I962MCQ71)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MENTHOL (UNII: L7T10EIP3A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    GINGER (UNII: C5529G5JPQ)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    HIMANTHALIA ELONGATA (UNII: 21RND18XRR)  
    MASTOCARPUS STELLATUS (UNII: 6T087FC66H)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65903-247-01118 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B04/01/2009
    Labeler - H2O Plus (807722947)
    Registrant - H2O Plus (807722947)
    Establishment
    NameAddressID/FEIBusiness Operations
    H2O Plus807722947manufacture
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