Lidocaine Hydrochloride
FDA Label NDC 69103-5000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Provision Medical for the product Lidocaine Hydrochloride (NDC 69103-5000). 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 active ingredient, purpose, uses, warnings, do not use, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Benzalkonium

Chloride 0.13% ...

Lidocaine

HCl 0.5%

Purpose

First aid

antiseptic

Topical

analgesic

Uses

  • temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria

Warnings

For external use only

Do Not Use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor

Keep Out Of Reach Of Children

If ingested contact a Poison Control Center right away.

Directions

  • clean affected area
  • apply small amount not more than 3 times daily
  • children under 2: consult a doctor

Inactive Ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Principal Display Panel – 0.9 G Packet Label

First Aid Burn Cream

The Provision
First Aid
Line™

For Burns
and Cuts

0.9 g (1/32 oz.)

Principal Display Panel – 0.9 G Packet Label (Pro23 0000 01)

Principal Display Panel – 0.9 G Packet Label (Pro23 0000 01)

* Please review the disclaimer below.