Label: FIRST AID ANTISEPTIC- benzalkonium chloride spray

  • NDC Code(s): 59898-401-10
  • Packager: Water-Jel Technologies
  • 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 December 21, 2020

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  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    First aid antiseptic

  • Uses

    first aid to help prevent infection in minor cuts, scrapes and burns

  • Warnings

    For external use only

    Do not use

    • in the eyes or apply over large areas of the body
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    • deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse

    Keep out of the reach of children

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

  • Directions

    • clean the affected area
    • spray a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

    • shake well
    • store at room temperature
    • you may report a serious adverse reaction to this product to 1-800-275-3433
  • Inactive ingredients


    diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol-9, propylene glycol, propylparaben, triethanolamine, water

  • Questions or comments?


    1-800-275-3433 info@waterjel.com www.waterjel.com
    Manufactered by Water-Jel Technologies, Inc., 50 Broad Street,
    Carlstadt, NJ 07072, USA

  • Principal Display Panel

    AS2

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISEPTIC 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-401-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/22/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/22/2010
    Labeler - Water-Jel Technologies (155522589)
    Registrant - Water-Jel Technologies (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(59898-401)
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