First Aid & Burn Cream 

First Aid & Burn Cream 
SPL v2
SPL
SPL Set ID 07d447f1-469c-4e34-b807-ede9a449e6ab
Route
TOPICAL
Published
Effective Date 2025-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (.13 g) Lidocaine (.5 g)
Inactive Ingredients
Aloe Barbadensis Leaf Juice Cetearyl Alcohol Disodium Hedta Ethylhexylglycerin Glyceryl Stearate/peg-100 Stearate Maltodextrin Mineral Oil Phenoxyethanol Propylene Glycol Stearic Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-18

Description

Active Ingredients (in each gram): Benzalkonium Chloride 0.13% Lidocaine HCl 0.5%


Medication Information

Warnings and Precautions

Warnings: For external use only. See a doctor immediately for serious burns

Indications and Usage

Uses: Temporary relief of pain and to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Dosage and Administration

Directions: do not use more than directed

Adults and children 2 years of age and over:

  • clean the affected area
  • apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

Description

Active Ingredients (in each gram): Benzalkonium Chloride 0.13% Lidocaine HCl 0.5%

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9

Stop use and ask a doctor if

  • condition lasts for more than 7 days
  • condition worsens
  • symptoms clear up and occur again within a few days
Section 50569-3

Ask a doctor before use if you have

  • serious burns
  • animal bites
  • deep or puncture wounds
Section 50570-1

Do not use:

  • in or near the eyes
  • over large portions of the body
  • in large quantities particularly over raw surfaces or blistered areas
  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily
Section 51727-6

Inactive Ingredients: aloe barbadensis leaf juice, cetearyl alcohol, disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate/PEG-100 stearate, maltodextrin, mineral oil, phenoxyethanol, propylene glycol, purified water, stearic acid, sodium hydroxide.

Section 51945-4

Section 55105-1

Purpose:

Topical Antiseptic

Topical Anesthetic

Section 55106-9

Active Ingredients (in each gram):

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%


Structured Label Content

Indications and Usage (34067-9)

Uses: Temporary relief of pain and to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Dosage and Administration (34068-7)

Directions: do not use more than directed

Adults and children 2 years of age and over:

  • clean the affected area
  • apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings: For external use only. See a doctor immediately for serious burns

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition lasts for more than 7 days
  • condition worsens
  • symptoms clear up and occur again within a few days
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • serious burns
  • animal bites
  • deep or puncture wounds
Section 50570-1 (50570-1)

Do not use:

  • in or near the eyes
  • over large portions of the body
  • in large quantities particularly over raw surfaces or blistered areas
  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily
Section 51727-6 (51727-6)

Inactive Ingredients: aloe barbadensis leaf juice, cetearyl alcohol, disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate/PEG-100 stearate, maltodextrin, mineral oil, phenoxyethanol, propylene glycol, purified water, stearic acid, sodium hydroxide.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Topical Antiseptic

Topical Anesthetic

Section 55106-9 (55106-9)

Active Ingredients (in each gram):

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%


Advanced Ingredient Data


Raw Label Data

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