Label: ANTIBACTERIAL FOAMING- 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 January 21, 2011

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.3 PERCENT

  • PURPOSE

    ANTISEPTIC

  • 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 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 WET HANDS, WORK INTO A LATHER.  RINSE THOROUGHLY.

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

  • INACTIVE INGREDIENTS

    WATER, SODIUM LAURETH SULFATE, GLYCERETH-26, DISODIUM LAURETH SULFOSUCCINATE, COCAMIDOPROPYL BETAINE, FRAGRANCE, PROPYLENE GLYCOL, PANTHENOL, ALOE BARBADENSIS LEAF JUICE, XANTHAN GUM, BENZOPHENONE-4, IMIDAZOLIDYNL UREA, DMDM HYDANTOI N, PEG-120 METHYL GLUCOSE DIOLEATE, PEG-7 GLYCERYL COCOATE, POLYSORBATE 20, TETRASODIUM EDTA, CITRIC ACID, BLUE 1 (CI 42090), YELLOW 10 (CI 47005).
  • PRINCIPAL DISPLAY PANEL

    IMAGE OF ANTIBACTERIAL FOAMING HSOAP

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL FOAMING   OLIVE AND ALOE
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    IMIDUREA (UNII: M629807ATL)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    GLYCERYL COCOATE (UNII: WVK1CT5994)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-170-08236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/21/2011
    Labeler - AMERICAN SALES COMPANY (809183973)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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