Label: WOODWARDS HANDCLENS FOAMING SANITIZER- benzalkonium chloride 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 October 20, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic Sanitizer

  • Uses

    When soap and water are not available.

    Kills germs and helps prevent infections in minor cuts and abrasions.

  • WARNINGS

    Do not use in eyes,ears or mouth. In case of eye contact, flush with water immediately.

    Stop use and ask a doctor if rash or irritation occurs or if condition persists.

    Keep out of reach of children under 2 years of age.

  • Directions

    Apply as needed and rub into skin. No rinsing necessary.

  • Inactive Ingredients

    Water, Didecyldimonium Chloride, Fragrance, Methylparaben, Propylparaben, Propylene Glycol, Diazolidinyl Urea, Allantoin, Cocamidopropylamine Oxide, Cetrimonium Chloride, Cocamidopropyl Betaine, Green 5, Violet 2, Triethanolamine, Citric Acid

  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    2 in 1
    Sanitizer & Lotion

    WOODWARD'S
    HandClens    ®

    Foaming Sanitizer & Lotion

    Alcohol-Free • Non-Flammable

    Softens Hands with Each Use!

    Kills 99.99%
    of Germs

    8 FL OZ (236 mL)

    Principal Display Panel - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    WOODWARDS HANDCLENS FOAMING SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60193-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALLANTOIN (UNII: 344S277G0Z)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60193-200-01236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:60193-200-031000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    3NDC:60193-200-051800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:60193-200-0750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A06/03/2013
    Labeler - Pacific World Corporation (089693097)
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