Burn
FDA Label NDC 62985-5082

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by First Aid Only, Inc for the product Burn (NDC 62985-5082). 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 other, active ingredients, purpose, uses, warnings, do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

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 area
  • Near eyes, if this happens rinse thoroughly with water

Otc - Stop Use

Stop use and ask doctor if condition worsens or persists for more than 7 days or clears up and returns

Otc - 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.

Directions

  • Adults and children 2 years of age and older; spray an even layer of burn spray over affected area not more than 3-4 times daily
  • For children under 2 years of age, consult a physician.

Inactive Ingredients

aloe vera, germaben II. Propylene glycol, purified water

Package Label.Principal Display Panel

Burn Spray

Pain relieving spray for use on minor burns.

M5082

3 fl. oz. (88.7 ml.)
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FIRST AID ONLY

Distributed by First Aid Only, Inc.

Vancouver, WA 96882 USA

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