Label: ANTIBACTERIAL MANDARIN- triclosan solution

  • 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 August 23, 2011

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.6%

  • PURPOSE

    ANTIBACTERIAL

  • USES

    FOR WASHING TO HELP DECREASE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    IRRITATION OR RASH DEVELOPS AND LASTS.

    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, VIGOROUSLY WORK INTO A LATHER AND RINSE THOROUGHLY.

  • INACTIVE INGREDIENTS

    WATER, SODIUM XYLENESULFONATE, SODIUM LAURETH SULFATE, DIPROPYLENE GLYCOL, COCAMIDOPROPYL BETAINE, POLYSORBATE 20, FRAGRANCE, DISODIUM PHOSPHATE, CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, YELLOW 5 (CI 19140), RED (CI 14700).

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF LABEL

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL  MANDARIN
    triclosan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-066
    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)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-066-08222 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/23/2011
    Labeler - TOPCO ASSOCIATES L LLC (006935977)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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