NORTH ANTISEPTIC FIRST AID- benzalkonium chloride and lidocaine spray, metered
North Safety Products, LLC.

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.

----------

NORTH Antiseptic Pump Spray

Active Ingredients

Benzalkonium Chloride 0.14%
Lidocaine 2.5%

Purpose

Topical Antiseptic
Topical Anesthetic

Uses

treatment of minor cuts, scratches and burns
pain relief
helps prevent infection
soothes itching

Warnings

For external use only

Do not use

in eyes or near mucous membranes
serious burns
deep puncture wounds
for a prolonged period of time

Stop use and ask a doctor if

irritation, redness, or swelling increases
rash or infection occurs

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

Directions

Hold 4-6 inches from surface
Spray area until wet

Inactive Ingredients

Isopropyl Alcohol, Water

Principal Display

image description

NORTH ANTISEPTIC FIRST AID
benzalkonium chloride and lidocaine spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-0016(NDC:52982-120)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	1912.5 mg in 90 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	107.1 mg in 90 mL

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0498-0016-10	60 mL in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/29/2014

Labeler - North Safety Products, LLC. (019777263)

Registrant - Dixon Investments, Inc. (115315822)

Name	Address	ID/FEI	Business Operations
Establishment
Dixon Investments, Inc.		115315822	manufacture(0498-0016)