Burn With Lidocaine Cream
FDA Label NDC 47682-260

13 label sections · Submitted to the FDA by Unifirst First Aid Corporation · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unifirst First Aid Corporation for the product Burn With Lidocaine (NDC 47682-260). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - 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

Otc - Active Ingredient

Active ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Otc - Purpose

Purpose

First aid antiseptic

Topicall analgesic

Indications & Usage

Uses

  • for the temporary releif of pain associated with minor burns
  • helps protect against harmful bacteria

Warnings

Warnings

For external use only.

Otc - Do Not Use

Do not use

  • in the eyes
  • in large quantities
  • over raw surfaces or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than 1 week unless directed by a doctor

Otc - Stop Use

Stop use and ask doctor if

  • the condition worsens or if symptoms persists for more than 7 days or clear up andoccur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If ingested, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

Adults and children 2 years and over:

  • clean the affected area, apply a small amount not more than 3 to 4 times daily

    • Children under 12 years:

    • do not use, consult a doctor

Other Safety Information

Other information

  • store at room temperature (do not freeze)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredient

Inactive ingredients

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

Otc - Questions

Questions or comments? 1-800-634-7680

Mf Burn Cream With Lidocaine Label

MEDI-FIRST®

BURN CREAM with Lidocaine

Benzalkonium Chloride 0.13% / Topical Antiseptic

Lidocaine HCl 0.5% / Topical Analgesic

Antiseptic and pain relieving cream for minor cuts, scrapes and burns

Product # 26073

0.9 gram Packets - 25 per box

* Please review the disclaimer below.