Burn Gel
FDA Label NDC 43473-048

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nantong Health & Beyond Hygienic Products Inc. for the product Burn (NDC 43473-048). 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 doctor if, 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 for minor burns.

Warnings:

For external use only

Do Not Use

  • ln large quantities, particularly over raw or blistered areas.
  • Near the eyes; if this happens rinse thoroughly with water.

Stop Use And Ask Doctor If

  • Condition worsens or persists for more than 7 days or clears up and occurs again within a few days.

Keep Out Of Reach Of Children.

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

Directions

  • For adults and children 2 years and older: apply to affected area not more than 4 times daily.
  • Children under 2 years old: do not use, consult a doctor.

Lnactive Lngredients

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

Burn Gel

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Image Of Pouch Label (Bg)

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