03f3c281-542b-6fca-e063-6394a90abec5

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
Purpose

Topical pain relief

Description

Lidocaine Hydrochloride 2%

Medication Information

Warnings

For external use only

Uses

Temporary pain relief associated with minor burns.

Purpose

Topical pain relief

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.
Inactive Ingredients

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

Description

Lidocaine Hydrochloride 2%

Section 51945-4

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%

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

Warnings

For external use only

Uses

Temporary pain relief associated with minor burns.

Purpose

Topical pain relief

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.
Inactive Ingredients (Inactive ingredients)

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

Section 51945-4 (51945-4)

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%

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