Label: ANTIBACTERIAL- 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 June 22, 2011

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  • ACTIVE INGREDIENT

    TRICLOSAN 0.15%

  • 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 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 THROUGHLY.

  • INACTIVE INGREDIENT

    WATER, SODIUM LAURETH SULFATE, SODIUM COCOYL SARCOSINATE, COCAMIDOPROPYL BETAINE, FRAGRANCE, PYRUS MALUS (APPLE) FRUIT EXTRACT, SODIUM PCA, BETAINE, SORBITOL, GLYCINE, ALANINE, PROLINE, SERINE, THREONINE, ARGININE, LYSINE, GLUTAMIC ACID, ALOE BARBADENSIS LEAF JUICE, PEG-120 METHYL GLUCOSE DIOLEATE, PEG-7 GLYCERYL COCOATE, TETRASODIUM EDTA, CITRIC ACID, SODIUM CHLORIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE.

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF ANTIBACTERIAL
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-282
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    APPLE (UNII: B423VGH5S9)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    BETAINE (UNII: 3SCV180C9W)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCINE (UNII: TE7660XO1C)  
    ALANINE (UNII: OF5P57N2ZX)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    SERINE (UNII: 452VLY9402)  
    THREONINE (UNII: 2ZD004190S)  
    ARGININE (UNII: 94ZLA3W45F)  
    LYSINE (UNII: K3Z4F929H6)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-282-08236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/22/2011
    Labeler - AMERICAN SALES COMPANY (809183973)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture