Lidocaine Hydrochloride Liquid
FDA Label NDC 84269-3500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wildman Business Group for the product Lidocaine Hydrochloride (NDC 84269-3500). 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 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 doctorif 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

Manufactured by SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077 www.safetec.com

PAIN RELIEF – Burn Spray 
Safetec of America

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Principal Display Panel – 2 Oz. Bottle

Principal Display Panel Burn Spray (Burn Sp 1)

Principal Display Panel Burn Spray (Burn Sp 1)

Provision

First Aid
Burn Spray

For Temporary
Pain Relief of
Minor Burns

2fl. oz. (59.1ml)

Reorder no. 3500

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