Genuine First Aid Burn Cream

Genuine First Aid Burn by

Drug Labeling and Warnings

Genuine First Aid Burn by is a Otc medication manufactured, distributed, or labeled by GFA Production (Xiamen) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GENUINE FIRST AID BURN- benzalkonium chloride, lidocaine hydrochloride cream 
GFA Production (Xiamen) Co., Ltd.

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Genuine First Aid Burn Cream

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCL 0.5%

Purpose:

First aid antiseptic, external analgesic.

Uses:

First aid to help prevent infection and for the temporary relief of pain and itching associated with: minor cuts, scrapes and burns.

Warnings:

For external use only.

Do not use:

in eyes, in large quantities, over raw blistered areas on deep puncture wounds, animal bites or serious burns, for more than one week.

Keep out of reach of children.

If ingested, contact a Poison Control Center right away.

Directions:

Clean affected area. Apply a small amount on area, not more than 3 times daily. May be covered with a sterile bandage.

Other information:

Store at room temperature.

Inactive ingredient:

Peregal-O 2.5%

Glycerin monostearate 2.5%

Glycerol 5%

Purified water.

Package Labeling:

GENUINE FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50814-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	13 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50814-005-01	1 in 1 BOX	03/23/2016	12/31/2025
1		0.9 g in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/23/2016	12/31/2025

Labeler - GFA Production (Xiamen) Co., Ltd. (421256261)

Revised: 10/2024

Document Id: 2406fe59-6bad-4913-e063-6294a90a13e6

34390-5

Set id: 65d59097-2982-4530-8f47-9b25235d10bf

Version: 7

Effective Time: 20241009