Label: WOODWARDS HANDCLENS FOAMING SANITIZER COLOR AND FRAGRANCE FREE- 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 ingredient

    Benzalkonium Chloride, 0.13%

  • Purpose

    Antiseptic Hand Sanitizer

  • Use

    for hand sanitizing to decrease bacteria on the skin

  • Warnings

    • For external use only

    When using this product

    • Avoid contact with eyes. In case of eye contact, flush with water

    • Stop use and ask a doctor if rash or irritation develops and lasts

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

  • Directions

    • Use enough foam to cover your hands
    • Rub hands together briskly until dry
  • Other information

    • Do not store above 110°F (40°C)
    • You may report questions or adverse reaction from using this product to 1(541)-476-3178, 8 am to 5 pm (M–F), PST
  • Inactive ingredients

    Water, Cocamidopropylamine Oxide, Didecyldimonium Chloride, Allantoin, Propylene Glycol, Cetrimonium Chloride, Cocamidopropyl Betaine, Sodium Hydroxide, Diazolidinyl Urea, Methylparaben, Propylparaben.

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

    Fragrance-Free
    Color-Free

    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

    1.7 FL OZ (50 mL)

    Principal Display Panel - 50 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    WOODWARDS HANDCLENS FOAMING SANITIZER COLOR AND FRAGRANCE FREE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60193-203
    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)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60193-203-01236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:60193-203-031000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
    3NDC:60193-203-051800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:60193-203-0750 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 FINALpart333A05/01/2014
    Labeler - Pacific World Corporation (089693097)
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