YOUR LOGO HERE ANTISEPTIC FIRST AID- benzalkonium chloride and lidocaine spray, metered 
Dixon Investments, Inc.

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.

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Your Logo Here Antiseptic Pump Spray

Active Ingredients

Benzalkonium Chloride 0.14%
Lidocaine 2.5%

Purposes

Topical Antiseptic
Topical Anesthetic

Uses

Treatment of minor cuts and abrasions
Pain Relief
Helps prevent infection
Soothes itching

Warnings

For external use only

Do not use

In eyes or near mucous membranes
For serious burns
Deep puncture wounds
For 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

YOUR LOGO HERE ANTISEPTIC FIRST AID 
benzalkonium chloride and lidocaine spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52982-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE1912.5 mg  in 90 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE107.1 mg  in 90 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52982-120-1390 mL in 1 BOTTLE, SPRAY
2NDC:52982-120-1260 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/05/2013
Labeler - Dixon Investments, Inc. (115315822)
Registrant - Dixon Investments, Inc. (115315822)
Establishment
NameAddressID/FEIBusiness Operations
Dixon Investments, Inc.115315822manufacture(52982-120)

Revised: 5/2013
Document Id: 96b179c7-bc85-441a-a78d-774d787b1fcc
Set id: ecda79f9-1bfc-4890-b18e-9fbe0fec2b01
Version: 3
Effective Time: 20130531
 
Dixon Investments, Inc.