43473-040 Burn Cream

43473-040 Burn Cream
SPL v2
SPL
SPL Set ID 186343c5-2e71-49c4-8d64-5fb3131239fa
Route
TOPICAL
Published
Effective Date 2024-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.5 g)
Inactive Ingredients
Triclosan Aloe Cetostearyl Alcohol Glycerin Water Disodium Hedta Ethylhexylglycerin Glyceryl Stearate/peg-100 Stearate Maltodextrin Phenoxyethanol Propylene Glycol Stearic Acid Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-02
Description

Active ingredient Benzalkonium Chloride 0.13% Lidocaine HCI         0.5%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor
Indications and Usage

Uses

Temporary relief of pain associated with minor cuts, scrapes, and burns.

Helps protect against harmful bacteria.

Dosage and Administration

Directions 

  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
Description

Active ingredient Benzalkonium Chloride 0.13% Lidocaine HCI         0.5%

Section 44425-7

Other Information

  • store at room temperature
  • tamper evident sealed packets
  • do not use any opened or torn packets
Section 50565-1

Keep out of reach of  children. If swallowed, get medical help or contact a Poison Control Center directly.

Section 51727-6

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate/PÉG-100 Stearate, Maltodextrin, Mineral Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine.

Section 51945-4

Section 55105-1

Purpose

First Aid Antiseptic

Topical Analgesic

Section 55106-9

Active ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCI         0.5%

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporary relief of pain associated with minor cuts, scrapes, and burns.

Helps protect against harmful bacteria.

Dosage and Administration (34068-7)

Directions 

  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage
Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor
Section 44425-7 (44425-7)

Other Information

  • store at room temperature
  • tamper evident sealed packets
  • do not use any opened or torn packets
Section 50565-1 (50565-1)

Keep out of reach of  children. If swallowed, get medical help or contact a Poison Control Center directly.

Section 51727-6 (51727-6)

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate/PÉG-100 Stearate, Maltodextrin, Mineral Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

First Aid Antiseptic

Topical Analgesic

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCI         0.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:13.978799 · Updated: 2026-03-14T23:03:12.694901