Lidocaine Hydrochloride
FDA Label NDC 0924-5000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acme United Corporation for the product Lidocaine Hydrochloride (NDC 0924-5000). 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, for external use only. keep out of reach of children., do not use, stop use and ask doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Active Ingredients

Lidocaine HCl 2%

Purpose

Topical pain relief

Uses

Temporary pain relief of minor burns. For professional use only.

For External Use Only. Keep Out Of Reach Of Children.

If ingested, get medical help or contact a Poison Control Center directly

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 Doctor If

  • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

Children under 2 years: do not use, consult a doctor

Other Information

  • store at room temperature (do not freeze)
  • do not use any opened or torn packs

Inactive Ingredients

aloe vera, carbomer, germaben II, menthol, propylene glycol, purified water, triethanolamine, Vitamin E acetate

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FIRST AID ONLY®

Burn Gel

For Temporary
Pain Relief of
Minor Burns

NET WT 3.5g

Distributed by

© 2016 Acme United Corporation.

Fairfield, CT 06824

1.800.835.2263

www.FirstAidOnly.com

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Principal Display Panel (Pouch Label)

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