FIRST AID ANTISEPTIC PAIN RELIEVING CREAM- benzalkonium chloride, lidocaine hydrochloride liquid

First Aid Antiseptic Pain Relieving Cream by

Drug Labeling and Warnings

First Aid Antiseptic Pain Relieving Cream by is a Otc medication manufactured, distributed, or labeled by Hubei Fanjian Medical Product Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Purpose

first aid antiseptic

pain reliever

Uses

first aid to help decrease the risk of infection in minor 

cuts  scrapes  burns  for the temporary relief of pain

Warnings

For external use only

Do not use

in the eyes

over large areas of the body

in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have

deep or puncture wounds  serious burns  animal bites

Stop use and ask a doctor if 

condition persists or gets worse

 you need to use this product for more than 1 week

Keep out of reach of children.

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

Directions

adults and children two years of age and older

clean the affected area apply a small amount of this product on the area 1 to 3 times daily

may be covered with a sterile bandage

children under 2 years of age: consult a doctor

Other information

Store at room temperature

Inactive ingredients

Glycerin monostearate, glycerol, purified water

Package Labeling:

INGREDIENTS AND APPEARANCE

FIRST AID ANTISEPTIC PAIN RELIEVING CREAM 
benzalkonium chloride, lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83165-004
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
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83165-004-00	1 in 1 PACKAGE	01/01/2023
1		0.9 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/01/2023

Labeler - Hubei Fanjian Medical Product Co.,Ltd (846385590)

Establishment
Name	Address	ID/FEI	Business Operations
Hubei Fanjian Medical Product Co.,Ltd		846385590	manufacture(83165-004)