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NDC 47682-0225-02 MediFirst Burn 20 g/L Details

MediFirst Burn 20 g/L

MediFirst Burn is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	47682-0225
Product ID	47682-225_ebdc8f15-5462-0bc8-e053-2995a90ac8f3
Associated GPIs	90850060102010
GCN Sequence Number	075612
GCN Sequence Number Description	lidocaine HCl SPRAY 2 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	40728
HICL Sequence Number	001478
HICL Sequence Number Description	LIDOCAINE HCL
Brand/Generic	Brand
Proprietary Name	MediFirst Burn
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	g/L
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Unifirst First Aid Corporation
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 47682-0225-02 (47682022502)

Pricing Information	N/A
NDC Package Code	47682-225-02
Billing NDC	47682022502
Package	.0591 L in 1 BOTTLE, SPRAY (47682-225-02)
Marketing Start Date	2013-04-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 9fa5b348-29c2-4cd0-a945-0486bd27f5e0 Details

Drug Facts

Active ingredient

Lidocaine HCl 2.0%

Purpose

Topical pain relief

Uses

Temporary pain relief associated with 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

Stop use and ask doctor if

condition worsens or persists for more than 7 days or clears up and returns.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
not to be used on children under 12 years of age

Inactive ingredients

aloe vera, germaben II, propylene glycol, purified water

Questions or Comments?

1-800-634-7680

Medi-First Burn Spray Label

MEDI-FIRST ®

Burn Spray

Pump Spray

Analgesic

Relieves pain in minor burns
Washable

2 FL OZ (59.1ML)

INGREDIENTS AND APPEARANCE

MEDIFIRST BURN

lidocaine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-225
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 g in 1 L

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47682-225-17	0.09 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/12/2013	04/02/2018
2	NDC:47682-225-02	0.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/12/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/12/2013

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 10/2022

Document Id: ebdc8f15-5462-0bc8-e053-2995a90ac8f3

Set id: 9fa5b348-29c2-4cd0-a945-0486bd27f5e0

Version: 11

Effective Time: 20221025