YOUR LOGO HERE BURN FIRST AID- benzalkonium chloride and benzocaine 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 BURN SPRAY WITH ALOE VERA

Active Ingredients

Benzalkonium Chloride 0.14%
Benzocaine 5.0% 

Purpose

Topical Antiseptic
Topical Anesthetic 

Uses

Treatment of minor cuts
Pain relief
Helps prevent infection 

Warnings

For external use only

Do not use

in eyes or near mucous membranes
For serious burns
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

Aloe Vera Gel, Isopropyl Alcohol, Menthol, Propylene Glycol, Water 

Principal Display

image description

YOUR LOGO HERE BURN FIRST AID 
benzalkonium chloride and benzocaine spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52982-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE3825 mg  in 90 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE107.1 mg  in 90 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MENTHOL (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52982-121-1390 mL in 1 BOTTLE, SPRAY
2NDC:52982-121-1259 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(52982-121)

Revised: 4/2013
Document Id: 64e5cbb3-590a-4c53-bcb6-0f9e06e20dfc
Set id: 84352da8-efd4-42d8-9284-2a795b3e3c53
Version: 1
Effective Time: 20130408
 
Dixon Investments, Inc.