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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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:

Label4

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/23/2016	12/31/2016

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

Revised: 12/2019

Document Id: 9a9c0250-13b4-6c6a-e053-2995a90aaa0b

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

Version: 6

Effective Time: 20191226

GFA Production (Xiamen) Co., Ltd.