Label: LIVE BETTER- benzalkonium chloride spray

  • 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 May 25, 2010

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  • Active Ingredient

    Benzalkonium Chloride

    Antimicrobial

  • Warnings

    For external use only, do not use in the eye area.

  • When using this product

    • avoid contact with eyes
    • in case of eye contact flush eyes with water
  • Stop use and ask a doctor if

    • irritation or redness develops or
    • if condition persists for more than 72 hours
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Pump one to three sprays onto palms of hands
    • Rub thoroughly over all surfaces of both hands
    • Rub hands together briskly until dry
    • Children under 6 should be supervised when using this product
    • Not recommended for infants
  • Other information

    • Store between 200 to 250 C (680 to 770 F)
    • Prior to initial use, prime pump by depressing multiple times
  • Inactive Ingredients

    Cetrimonium Chloride, Citrus Fragrance, Disodium EDTA, DI Water

  • PRINCIPAL DISPLAY PANEL

    MM12Live better bottle label

  • PRINCIPAL DISPLAY PANEL

    MM13Live Better blister card

  • PRINCIPAL DISPLAY PANEL

    MM14Live Better shipper label

  • INGREDIENTS AND APPEARANCE
    LIVE BETTER   HAND SANITIZER
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48871-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride.0013 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cetrimonium Chloride (UNII: UC9PE95IBP)  
    Edetate disodium (UNII: 7FLD91C86K)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48871-003-016 in 1 CASE
    112 in 1 CARTON
    12 in 1 BLISTER PACK
    17.5 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/31/2010
    Labeler - Health-Tech, Inc. (084007889)
    Establishment
    NameAddressID/FEIBusiness Operations
    Health-Tech, Inc.084007889manufacture
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