Label: ANTIBACTERIAL FOAMING CUCUMBER MELON- triclosan liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 2, 2011

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  • Active Ingredient

    Triclosan 0.6%

  • Purpose

    Antibacterial

  • Uses

    Helps reduce bacteria on the skin.

  • WARNINGS

    For external use only.

    When using this product

    Avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

    Stop using this product and ask doctor if

    if irritation and redness develop.

    Keep out of reach of children

    In case of accidental ingestion, get medical help or contact Poison Control Center immediately.

  • Directions

    Pump onto dry hands, work into a lather and rinse thoroughly.

  • Other information

    Enter section text here

  • Inactive ingredients

    Water, Sodium Xylenesulfonate, Dipropylene Glycol, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Fragrance, Disodium Phosphate, Citric Acid, Blue 1 (CI 42090), Yellow 5 (CI 19140), Red 40 (CI 16035).

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL FOAMING  CUCUMBER MELON
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-067
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-067-08222 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/02/2011
    Labeler - Topco Associates llc (006935977)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture
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