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

GENUINE FIRST AID Antiseptic Pain Relieving by

Drug Labeling and Warnings

GENUINE FIRST AID Antiseptic Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Nantong Health & Beyond Hygienic Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCL 0.5%

PURPOSE

Purpose

First Aid Antiseptic

Topical Analgesic

INDICATIONS & USAGE

Uses

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

Helps protect against harmful bacteria

WARNINGS

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center directly.

DOSAGE & ADMINISTRATION

Directions 

Clean affected area

Apply small amount not more than 3 times daily

Maybe covered with a sterile bandage

STORAGE AND HANDLING

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

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

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