Label: DIAL ACNE ACNE- triclocarban soap

  • 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 June 6, 2014

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  • ACTIVE INGREDIENT

    Salicylic acid

  • PURPOSE

    Acne Treatment

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical

    help or contact Poison Control right away.

  • USE

    For the treatment of acne

  • WARNINGS

    For external use only, avoid contact with eyes. If contact occurs flush thoroughly with water.

  • USE

    wet bar with water - lather vigorously -

    and wash skin - rinse and dry thoroughly

  • QUESTIONS

    1-800-258 (DIAL)

  • Inactive ingredients

    Soap (sodium tallowate, sodium cocoate, sodium palm kernelate, sodium palmate), water, glycerin, PEG-8, coconut acid, palm acid, tallow acid, palm kernel acid, fragrance, citrus aurantium dulcis (orange) juice, citrus paradisi (grapefruit) juice, passiflora edulis fruit juice, sodium chloride, pentasodium pentetate, Tetrasodium etidronate, yellow 5, red 4

  • PRINCIPAL DISPLAY PANEL

    Acne.jpg

  • INGREDIENTS AND APPEARANCE
    DIAL ACNE  ACNE
    triclocarban soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51815-307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID4.8 g  in 240 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    Water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCONUT ACID (UNII: 40U37V505D)  
    PALM ACID (UNII: B6G0Y5Z616)  
    TALLOW ACID, BEEF (UNII: 5U9XZ261ER)  
    PALM KERNEL ACID (UNII: 79P21R4317)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    CITRUS PARADISI FRUIT OIL (UNII: 6A7N43E0OJ)  
    PASSIFLORA EDULIS FRUIT JUICE (UNII: JS28QQ039D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Product Characteristics
    ColoryellowScore    
    ShapeOVALSize
    FlavorImprint Code Dial
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51815-307-00240 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/27/2014
    Labeler - VVF Illinois Services LLC (024177178)
    Establishment
    NameAddressID/FEIBusiness Operations
    VVF Illinois Services LLC024177178manufacture(51815-307)
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