Label: MEDLINE- benzalkonium chloride, lidocain hydrochloride spray

  • NDC Code(s): 53329-918-04
  • Packager: Medline Industries, LP
  • 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 July 26, 2022

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  • Active ingredients

    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 are
    • 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

    camphor, propylene glycol, purified water, 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: MDSCLEAN4

    V1RF21WIP

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    benzalkonium chloride, lidocain hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-918
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-918-04113 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 not finalpart333A05/01/2021
    Labeler - Medline Industries, LP (025460908)
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