Label: HEALTH STAT- 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 March 23, 2010

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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 chloride, 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

  • Health Stat 6215 1000 ml bag

    6215M5P5122A.jpg  Health Stat 1000 ml bagimage of bag label

  • INGREDIENTS AND APPEARANCE
    HEALTH STAT 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63551-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.003 mL  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 CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63551-220-131 in 1 BOX
    1800 mL in 1 BAG
    2NDC:63551-220-17437 mL in 1 BOTTLE, PLASTIC
    3NDC:63551-220-05540 mL in 1 BOTTLE, PLASTIC
    4NDC:63551-220-111000 mL in 1 BOTTLE, PLASTIC
    5NDC:63551-220-181000 mL in 1 BAG
    6NDC:63551-220-143785 mL in 1 BOTTLE, PLASTIC
    7NDC:63551-220-15946 mL in 1 BOTTLE, PLASTIC
    8NDC:63551-220-121 in 1 BOX
    81000 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33312/18/2000
    Labeler - Triad Group (050259597)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture
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