43473-062 Po First Aid Series Burn Gel

43473-062 Po First Aid Series Burn Gel
SPL v1
SPL
SPL Set ID f1c349a8-216d-4233-922e-c95329a33d1e
Route
TOPICAL
Published
Effective Date 2024-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Water Aloe Vera Leaf Carbomer 934 Menthol Ethylhexylglycerin Maltodextrin Phenoxyethanol Propylene Glycol Triclosan .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-05
Description

Active ingredient Lidocaine HCI         2%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

Temporary relief of pain associated with minor burns.

Dosage and Administration

Directions

■ Apply an even layer of burn gel over deaned affected area not more than 3-4 times daily

■ not to be used on children under 12 years of age.

Description

Active ingredient Lidocaine HCI         2%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctorif the condition worsens or persists for more than 7 days or clears up and returns

Section 50570-1

Do not use

■ in large quantities, particularly over raw or blistered areas

■ near eyes, if this happens rinse thoroughly with water

Section 51727-6

Inactive ingredients

Aloe Barbadensis Leaf Juice, Carbomer, Ethylhexgilglycerin, Maltodextrin, Menthol, Polyethylene Glycol, Phenoxyethanol, Triethanolamine, Tocopheryl Acetate, Water.

Section 51945-4

Section 55105-1

Purpose

Topical Pain Relief

Section 55106-9

Active ingredient

Lidocaine HCI         2%

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporary relief of pain associated with minor burns.

Dosage and Administration (34068-7)

Directions

■ Apply an even layer of burn gel over deaned affected area not more than 3-4 times daily

■ not to be used on children under 12 years of age.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctorif the condition worsens or persists for more than 7 days or clears up and returns

Section 50570-1 (50570-1)

Do not use

■ in large quantities, particularly over raw or blistered areas

■ near eyes, if this happens rinse thoroughly with water

Section 51727-6 (51727-6)

Inactive ingredients

Aloe Barbadensis Leaf Juice, Carbomer, Ethylhexgilglycerin, Maltodextrin, Menthol, Polyethylene Glycol, Phenoxyethanol, Triethanolamine, Tocopheryl Acetate, Water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical Pain Relief

Section 55106-9 (55106-9)

Active ingredient

Lidocaine HCI         2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.160502 · Updated: 2026-03-14T23:05:33.999008