Label: ANTIBACTERIAL LIQUID HAND- 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 November 18, 2010

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  • ACTIVE INGREDIENT

    Active ingredient
    Triclosan 0.115%

    Purpose
    Antibacterial
  • INDICATIONS & USAGE

    Uses for handwashing to decrease bacteria on the skin
  • WARNINGS

    Warnings
    For external use only    .

    When using this product • do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.

    Keep out of reach of children.  if swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions  •Wet hands  •Apply palmful to hands  •Scrub thoroughly •Rinse
  • INACTIVE INGREDIENT

    Inactive ingredients water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, sodium chloride, decyl glucoside, fragrance, DMDM hydantoin, PEG-120 methyl glucose dioleate, cocamide MEA, citric acid, tetrasoidum EDTA, polyquaternium-7, PEG-7 glyceryl cocoate, D+C red no. 33, FD+C, blue no. 1
  • ADVERSE REACTIONS

    Distributed by OnPoint, Inc
    2 Paragon Drive, Montvale, NJ 07645
  • PRINCIPAL DISPLAY PANEL

    MARKET SPA
    ANTIBACTERIAL
    LIQUID HAND SOAP
    CLEAR FORMULA
    7.5 FL OZ (221 mL)
    image of principal display panel

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL LIQUID HAND 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51143-541
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN.115 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51143-541-931.18 L in 1 BOTTLE, PLASTIC
    2NDC:51143-541-96.221 L in 1 BOTTLE, PLASTIC
    3NDC:51143-541-971.89 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/30/2009
    Labeler - OnPoint, Inc (001367366)
    Registrant - Vi Jon (150931459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon150931459manufacture
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