919 medline burn spray

919 medline burn spray
SPL v6
SPL
SPL Set ID b0b5ff82-db36-7708-e053-2a95a90ad9bb
Route
topical
Published
Effective Date 2021-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (4 g)
Inactive Ingredients
sodium hydroxide aloe vera leaf water camphor (synthetic) propylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-05-01

Purpose

First aid antiseptic Topical pain reliever

Description

Benzalkonium chloride 0.13% w/w Lidocaine HCl 4% w/w


Medication Information

Warnings

For external use only.

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
Purpose

First aid antiseptic

Topical pain reliever

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

Description

Benzalkonium chloride 0.13% w/w Lidocaine HCl 4% w/w

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
Package Label

Active Ingredient

Benzalkonium chloride 0.13% w/w

Lidocaine HCl 4% w/w

Questions Or Comments?

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

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
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

Keep Out of Reach of Children.

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

Stop Use and Consult A Doctor If
  • condition persists or gets worse
Ask A Doctor Before Use If You Have
  • deep puncture wounds, animal bites or serious burns

Structured Label Content

Warnings

For external use only.

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
Purpose

First aid antiseptic

Topical pain reliever

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 (Inactive ingredients)

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

Do Not Use (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
Package Label

Active Ingredient (Active ingredient)

Benzalkonium chloride 0.13% w/w

Lidocaine HCl 4% w/w

Questions Or Comments? (Questions or comments?)

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

When Using This Product (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
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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)
  • condition persists or gets worse
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep puncture wounds, animal bites or serious burns

Advanced Ingredient Data


Raw Label Data

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