Label: LIQUID HAND CLEANSE- triclosan gel

  • 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 July 5, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient                 Purpose

    Triclosan 0.2%......................Antiseptic

  • PURPOSE

    Health Care Instant Hand Sanitizer - Ice Clear - Extra Enriched with Vitamin E Bead & Aloe

    Kills 99.9% of Germs without water or towels!

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    USE: 

    • handwashing to decrease bacteria on the skin
  • WARNINGS

    Warnings:

    for external use only.

    Flammable. Keep away from heat and flame.

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

  • DOSAGE & ADMINISTRATION

    Directions:

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • supervise children in the use of this product
  • INACTIVE INGREDIENT

    Inactive ingredients:

    aloe vera leaf juice, carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water.

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • INGREDIENTS AND APPEARANCE
    LIQUID HAND CLEANSE 
    triclosan gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-316
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN10 mg  in 500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-7 (UNII: 4ST6952Q67)  
    ETHYL SULFATE (UNII: P3LK0HF3B7)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DIETHANOLAMINE (UNII: AZE05TDV2V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    OCTHILINONE (UNII: 4LFS24GD0V)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-316-01500 mg in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/05/2013
    Labeler - Great Lakes Wholesale & Marketing, LLC (361925498)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(64092-316)
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