Label: ANTIBAC FOAM WASH- triclosan soap

  • 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 27, 2011

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  • Drug Facts Box OTC-Active Ingredient Section

    Triclosan 0.3%

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • Drug Facts Box OTC-Indications & Usage Section

    for hand-washing to decrease bacteria on the skin

  • Drug Facts Box OTC-Warnings Section

    For external use only

  • Drug Facts Box OTC-When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • Drug Facts Box OTC-Stop Use Section

    irritation and redness develop

  • Drug Facts Box OTC-Keep Out of Reach of Children Section

    if swallowed, get medical help or contact a Poison Control Center right away

  • Drug Facts Box OTC-Dosage & Administration Section


    wet hands and forearms

    apply 5 milliliters (teaspoonful) or palmful to hands and forearms

    scrub thoroughly for 1 minute and rinse

  • Drug Facts Box OTC-Inactive Ingredient Section

    water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, alcohol denat., propylene glycol, tetrasodium EDTA, PEG-75 lanolin,  boric acid, lauramine oxide, chloroxylenol, methylparaben, propylparaben, fragrance, aloe barbadensis, acid red 1, reactive green 12

  • Antibac Foam Wash 6576 650 ml bag

    6576B6P5488.jpg  Antibac Foam Wash  650 ml bag  image of bag label

  • INGREDIENTS AND APPEARANCE
    ANTIBAC FOAM WASH 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59503-6576
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    BORIC ACID (UNII: R57ZHV85D4)  
    ALCOHOL (UNII: 3K9958V90M)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59503-6576-9650 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/27/2011
    Labeler - Rochester Midland Corporation (002207041)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture
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