Lidocaine Hydrochloride
FDA Label NDC 69103-5100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Provision Medical for the product Lidocaine Hydrochloride (NDC 69103-5100). 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 active ingredients, purpose, uses, warnings, do not use, otc - stop use, otc - 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 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

Principal Display Panel – 2 Fl. Oz Bottle Label

The Provision
First Aid
Line™

First Aid
Burn Spray

For Temporary
Pain Relief of
Minor Burns

2 fl. oz. (59.1 ml)

Reorder no. 3500

Principal Display Panel – 2 Fl. Oz Bottle Label (Pro24 0000 01)

Principal Display Panel – 2 Fl. Oz Bottle Label (Pro24 0000 01)

* Please review the disclaimer below.