Burn
FDA Label NDC 72459-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yiwu Ori-power Medtech Co., Ltd. for the product Burn (NDC 72459-101). 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 and ask a doctor, 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 Hydrochloride 2%

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 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.

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