Label: ANTIBACTERIAL FOAMING HAND SP CLEAN AND MILD- 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 February 3, 2011

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.6%

  • PURPOSE

    ANTIBACTERIAL

  • USES

    FOR WASHING TO DECREASE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

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

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    PUMP ONTO DRY HANDS.  WORK INTO LATHER VIGOROUSLY.  RINSE THOROUGHLY.

  • INACTIVE INGREDIENTS

    WATER, SODIUM XYLENESULFONATE,  DIPROPYLENE GLYCOL,  AMMONIUM LAURYL SULFATE,  COCAMIDOPROPYL BETAINE,  FRAGRANCE,  DISODIUM PHOSPHATE,  CITRIC ACID, RED 4 (CI 14700),YELLOW 5 (CI 19140).

  • QUESTIONS OR COMMENTS

    1-800-748-7287

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF ANTIBACTERIAL FOAMING HSOAP

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL FOAMING HAND SP  CLEAN AND MILD
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-169
    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 2,5-DIMETHYLBENZENE-1-SULFONATE (UNII: O34Z1LTN62)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-169-08221 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/03/2011
    Labeler - CVS PHARMACY (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture