FDA.reportPublic FDA data

919 Medline Burn Spray

Manufacturer
Medline Industries, LP
Effective date
2025-09-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:13:26

Label at a glance#

ProductMedline
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure9 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13% w/w

Lidocaine HCl 4% w/w

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Topical pain reliever

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • deep puncture wounds, animal bites or serious burns

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • condition persists or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

Manufacturing Information

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SprayPSN6
2047877benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCD6
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SpraySY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-919-042025-09-10C16284748780-13b156c62-2fb6-fb37-e063-e6dba90a4e07919 Medline Burn Spray
53329-919-042025-07-29C16284748780-13b156c62-2fb6-fb37-e063-e6dba90a4e07919 Medline Burn Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-919-04Medline113 g in 1 BOTTLE, SPRAYSPRAY1136

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-91953329-919-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SODIUM HYDROXIDE55X04QC32IIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineBENZALKONIUM CHLORIDE, LIDOCAIN HYDROCHLORIDEMedline Industries, LPb0b5ff82-db36-7708-e053-2a95a90ad9bb2025-09-09WarningsExact identifier
ndc (package): 53329-919-04
ndc (product): 53329-919
ndc11 (package): 53329091904
spl id: 3e6288db-68c6-ffaf-e063-6394a90a4eb4
spl set id: b0b5ff82-db36-7708-e053-2a95a90ad9bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.