MedPath

Medline

919 Medline Burn Spray

Approved
Approval ID

b0b5ff82-db36-7708-e053-2a95a90ad9bb

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Medline Industries, LP

DUNS: 025460908

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

benzalkonium chloride, lidocain hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53329-919
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
benzalkonium chloride, lidocain hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (7)

LIDOCAINE HYDROCHLORIDEActive
Quantity: 4 g in 100 g
Code: V13007Z41A
Classification: ACTIR
BENZALKONIUM CHLORIDEActive
Quantity: 0.13 g in 100 g
Code: F5UM2KM3W7
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CAMPHOR (SYNTHETIC)Inactive
Code: 5TJD82A1ET
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/1/2021

Package Label

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/1/2021

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/1/2021

Active ingredient

Benzalkonium chloride 0.13% w/w

Lidocaine HCl 4% w/w

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/1/2021

Purpose

First aid antiseptic

Topical pain reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 5/1/2021

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/1/2021

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 5/1/2021

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/1/2021

Questions or comments?

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/1/2021

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

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Medline - FDA Drug Approval Details