GENUINE FIRST AID PAIN RELIEVING CREAM- benzalkonium chloride, lidocaine hydrochloride cream

Genuine First Aid Pain Relieving Cream by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

• Temporary relief of pain associated with minor cuts, scrapes, and burns.
• Helps pretect against harmful bacteria.

Warnings

For external use only.

Do not use

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

Keep out of the reach of children.

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

Directions

• clean affected area
• apply small amount not more than 3 times daily
• may be covered with a sterile bandage

Other information

• store in a cool dry area 15° to 25° C (59° to 79°F)
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate/PEG-100 Stearate, Maltodextrin, Mineral Oil, Phenoxyethanol, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine

Package Labeling:

INGREDIENTS AND APPEARANCE

GENUINE FIRST AID PAIN RELIEVING CREAM 
benzalkonium chloride, lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50814-079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50814-079-01	0.9 g in 1 TUBE; Type 0: Not a Combination Product	11/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	11/01/2023

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