Medline
919 Medline Burn Spray
b0b5ff82-db36-7708-e053-2a95a90ad9bb
HUMAN OTC DRUG LABEL
Sep 9, 2025
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
Product Classification
Product Specifications
INGREDIENTS (7)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package Label
INDICATIONS & USAGE SECTION
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
Active ingredient
Benzalkonium chloride 0.13% w/w
Lidocaine HCl 4% w/w
OTC - PURPOSE SECTION
Purpose
First aid antiseptic
Topical pain reliever
WARNINGS SECTION
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
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
Inactive ingredients
aloe vera gel, camphor, propylene glycol, purified water USP, sodium hydroxide
OTC - QUESTIONS SECTION
Questions or comments?
1-800-MEDLINEMonday-Friday 8:30 a.m.-5:00 p.m. EST
SPL UNCLASSIFIED SECTION
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
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