FIRST DEGREE BURN- benzocaine, triclosan spray 
The Akshay Wellness Group, 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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First°Degree® Burn Spray

Active ingredients

Benzocaine 20.0%

Triclosan 0.13%

Purpose

Pain relieving spray

First aid antiseptic

Uses

Warnings

For external use only.

Flammable: Do not use while smoking or near heat or flame.

Do not use

When using this product

Ask a Physician before use if you have

Stop use and ask a physician if

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

SD Alcohol 40, Propylene Glycol, Disopropyl Adipate, Tocopheryl Acetate (Vitamin E Acetate)

Questions or comments?

1-888-565-BURNCARE (565-2876)
Monday through Friday, 9am-5pm

Principal Display Panel

Maximum Pain Relief

First°Degree® Burn Spray

Sprays at an angle!

Burns Happen. Be Prepared.™

Net Wt. 3 oz (85 g)

Drug Facts Panel

First Degree Burn Spray Bottle Label

Bottle Label

FIRST DEGREE BURN 
benzocaine, triclosan spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24330-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24330-111-8589 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2013
Labeler - The Akshay Wellness Group, Inc. (802294863)

Revised: 7/2013
Document Id: 8bbc5057-7e59-4b84-ab30-b775b1a18dd3
Set id: 8bbc5057-7e59-4b84-ab30-b775b1a18dd3
Version: 1
Effective Time: 20130725
 
The Akshay Wellness Group, Inc.