MedPath

Medi-First Burn

Medi-First Burn Gel Drug Facts

Approved
Approval ID

44bb5f25-1114-4bb1-8bcf-40402594abc4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Unifirst First Aid Corporation

DUNS: 832947092

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code47682-477
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine Hydrochloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (11)

DIAZOLIDINYL UREAInactive
Code: H5RIZ3MPW4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)Inactive
Code: 59TL3WG5CO
Classification: IACT
LIDOCAINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 g
Code: V13007Z41A
Classification: ACTIR
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/1/2020

Medi-First Burn Gel Label

Medi-First ®

Burn Gel

Lidocaine HCl / Topical Analgesic

Product # 47769

NET CONTENTS: 6 Units of 1/8 oz

MF BurnGel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/30/2014

Uses

For the temporary relief of pain associated with minor burns.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/30/2014

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/13/2016

Active ingredient (in each gram)

Lidocaine HCI 2.0%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/13/2016

Purpose

Topical analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 10/13/2016

Warnings

For external use only.

Do not use

  • in large quantities, particularly over raw or blistered areas

When using this product

  • avoid contact with the eyes

Stop use ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clears up and occurs again within a few days

Keep out of the reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/13/2016

Directions

*adults & children 2 years and older: apply to affected area not more than 3 to 4 times daily *children under 2: consult a doctor

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/13/2016

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/13/2016

Questions?

Call 1-800-634-7680

Mfg. for Medique Products, 17080 Alico Commerce Ct., Ste 1, Fort Myers, FL 33967

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Medi-First Burn - FDA Drug Approval Details