Label: FIRST AID ANTISPETIC- 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 March 18, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    Flammable keep away from fire or flame

  • Do not use

    • near eyes or mucous membranes
    • on deep or puncture wounds , animal bites, or serious burns
    • over large areas of the body
    • more than one week unless directed by a doctor
  • Stop use and ask a doctor

    if condition persists or gets worse

  • Keep out of reach of children.

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

  • Directions

    • clean affected area & spray 1 to 3 times daily
    • may be covered with a sterile bandage
    • not to be used on children under 12 of years of age
  • Inactive ingredients

    ethyl alcohol, purified water

  • Questions or comments？

    1-800-480-5855

  • Package Label - Principal Display Panel

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISPETIC 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49314-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49314-0001-159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/20/2023
    Labeler - Unishield (790677053)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!