FIRST DEGREE BURN- benzocaine, triclosan spray

First Degree Burn by

Drug Labeling and Warnings

First Degree Burn by is a Otc medication manufactured, distributed, or labeled by The Akshay Wellness Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Benzocaine 20.0%

Triclosan 0.13%

Purpose

Pain relieving spray

First aid antiseptic

Uses

• for temporary relief of pain and itching from minor burns, cuts and scrapes
• first aid to help prevent infection in minor burns, cuts and scrapes

Warnings

For external use only.

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

Do not use

• in the eyes
• over large areas of the body

When using this product

• keep out of eyes
• use only as directed
• do not puncture or incinerate. Contents under pressure. Do not store at
  temperature above 120°F.

Ask a Physician before use if you have

• serious burns
• deep or puncture wounds
• existing infection
• animal bites

Stop use and ask a physician if

• conditions persist or worsen
• rash or other allergic reaction develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• needed for longer than 1 week

Keep out of reach of children.

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

Directions

• shake well
• adults and children 2 years of age and older: clean affected area, spray small amount of this product on the area, not more than 1 to 3 times daily
• if bandaged, let dry first
• children under 2 years of age: consult a physician
• to apply to face, spray into palm of hand and gently apply

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

• instant pain relief
• helps prevent infection
• cools burn on contact

Sprays at an angle!

Burns Happen. Be Prepared.™

Net Wt. 3 oz (85 g)

Drug Facts Panel

Bottle Label

INGREDIENTS AND APPEARANCE

FIRST DEGREE BURN 
benzocaine, triclosan spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24330-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 mL
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24330-111-85	89 mL in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2013

Labeler - The Akshay Wellness Group, Inc. (802294863)