burn

burn
SPL v3
SPL
SPL Set ID d4b09055-b93e-466f-9e24-cae098af6e24
Route
topical
Published
Effective Date 2025-06-02
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 drug active Since 2022-10-01

Purpose

Topical pain relief

Description

Lidocaine HCl 2.0%


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 gel over cleaned affected area
  • not to be used on children under 12 years
Inactive Ingredients

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

Description

Lidocaine HCl 2.0%

Stop Use

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

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

Product Label

Active Ingredient

Lidocaine HCl 2.0%

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 gel over cleaned affected area
  • not to be used on children under 12 years
Inactive Ingredients (Inactive ingredients)

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

Stop Use (Stop use)

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

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

Product Label (Product label)

Active Ingredient (Active ingredient)

Lidocaine HCl 2.0%

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

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