Label: MEDLINE- benzalkonium chloride, lidocain hydrochloride spray

  • NDC Code(s): 53329-919-04
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 10, 2024

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  • Active ingredient

    Benzalkonium chloride 0.13% w/w

    Lidocaine HCl 4% w/w

  • Purpose

    First aid antiseptic

    Topical pain reliever

  • Uses

    • first aid to help prevent the risk of bacterial contamination in minor cuts, scrapes, and burns
    • for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations
  • 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
    • in large quantities, particularly over raw surfaces or blistered areas

    Ask a doctor before use if you have

    • deep puncture wounds, animal bites or serious burns

    When using this product

    • contents under pressure
    • do not puncture or incinerate
    • store at temperatures between 45°-130°F (7°-54°C), avoid excessive heat

    Stop use and consult a doctor if

    • condition persists or gets worse

    Keep out of reach of children.

    If accidentally ingested, 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 a day
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Inactive ingredients

    aloe vera gel, camphor, propylene glycol, purified water USP, sodium hydroxide

  • Questions or comments?

    1-800-MEDLINE Monday-Friday 8:30 a.m.-5:00 p.m. EST

  • Manufacturing Information

    Manufactured for: Medline Industries, Inc.

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA of foreign and domestic materials

    www.medline.com

    1-800-MEDLINE

    REF: MDSBURN4

    V3RH22WIP

  • Package Label

    label

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    benzalkonium chloride, lidocain hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-919
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-919-04113 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/01/2021
    Labeler - Medline Industries, LP (025460908)
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