SPL v1
SPL
SPL Set ID 03f3c281-542b-6fca-e063-6394a90abec5
Route
TOPICAL
Published
Effective Date 2023-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Ethylhexylglycerin Maltodextrin Menthol Polyethylene Glycol, Unspecified Phenoxyethanol Trolamine .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-08-28
Description

Lidocaine Hydrochloride 2%

Purpose

Topical pain relief

Medication Information

Purpose

Topical pain relief

Description

Lidocaine Hydrochloride 2%

Uses

Temporary pain relief associated with minor burns.

Section 51945-4

Warnings

For external use only

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.
Do Not Use
  • in large quantities, particularly over raw or blistered areas.
  • near eyes, if this happens rinse thoroughly with water.
Active Ingredient

Lidocaine Hydrochloride 2%

Inactive Ingredients

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

Stop Use and Ask A Doctor

if the condition worsens or persists for more than 7 days or clears up and returns.

Keep Out of Reach of Children.

If swallowed get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

Temporary pain relief associated with minor burns.

Section 51945-4 (51945-4)

Purpose

Topical pain relief

Warnings

For external use only

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.
Do Not Use (Do not use)
  • in large quantities, particularly over raw or blistered areas.
  • near eyes, if this happens rinse thoroughly with water.
Active Ingredient (Active ingredient)

Lidocaine Hydrochloride 2%

Inactive Ingredients (Inactive ingredients)

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

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if the condition worsens or persists for more than 7 days or clears up and returns.

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

If swallowed get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:13.240814 · Updated: 2026-03-14T23:01:17.657881