43473-015 Genuine First Aid Antiseptic Pain Relieving

Active ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCL 0.5%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

Temporary relief of pain assocoated with minor cuts, scrapes, and burns.

Helps protect 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 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

Maybe covered with a sterile bandage

Other information

Store in a cool area 15C to 25C (59F to 77F)

Temper evident sealed packats

Do not use any opened or torn packets

Inactive ingredients

Aloe barbadensis leaf jiuce, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glyceryl stearate/ PEG-100 Stearate, Glycerin, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, Water, Stearic acid, Triethanolamine

image description

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43473-015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISODIUM HEDTA (UNII: KME849MC7A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRICLOSAN (UNII: 4NM5039Y5X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43473-015-01	0.9 g in 1 POUCH; Type 0: Not a Combination Product	10/19/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	10/19/2023

Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)

Name	Address	ID/FEI	Business Operations
Establishment
Nantong Health & Beyond Hygienic Products Inc.		421280161	manufacture(43473-015)