Burn Gel
FDA Label NDC 82942-1001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by J&a Digital Inc. for the product Burn (NDC 82942-1001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, stop use, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

temporary pain relief associated with minor burns

Warnings

For external use only

Do Not Use

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with 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.

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.

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