First Aid Burn
FDA Label NDC 49314-5100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unishield for the product First Aid Burn (NDC 49314-5100). 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.

Other

Drug Facts

Active Ingredients

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief for 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

Otc - Stop Use

Stop use and ask a 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 Poison Control Center right away

Directions

  • for adults and children 2 years of age and older: spray an even layer of burn spray over cleaned 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

Questions?

call 1-800-480-5855

Principal Display Panel - 59.1 Ml Bottle Label

UniShield

FIRST AID
BURN
SPRAY

For Temporary
Pain Relief of
Minor Burns

NET CONTENTS 2 FL.OZ. (59.1 ML)

Distributed by: UniShield, San Fernando, CA 91340
Made in USA

Principal Display Panel (59.1 mL Bottle Label)

Principal Display Panel (59.1 mL Bottle Label)

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