AMERICAINE- benzocaine aerosol, spray

Americaine by

Drug Labeling and Warnings

Americaine by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Americaine® 
Benzocaine 
Topical Anesthetic Spray

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Topical Anesthetic

Uses

temporarily relieves pain and itching associated with:

• minor cuts
  
• scrapes
  
• minor burns
  
• insect bites

Warnings

For external use only

Flammability Warning

Contents under pressure. Do not puncture or incinerate. Flammable mixture; do not use near fire or flame, or expose to heat or temperatures above 49°C (120°F). Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

• condition worsens, or symptoms persists for more than 7 days
  
• symptoms do not get better, or if redness, irritation, swelling, pain or other symptoms occur or increase

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• shake can well, hold 6" to 12" from affected area; spray liberally.
  
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  
• children under 2 years of age: consult a physician

Inactive ingredients

Polyethylene glycol 300 
Propellant: Isobutane, normal butane, propane

Store at room temperature 15°– 25°C (59°– 77°F).

Questions?

1-800-344-7239

PRINCIPAL DISPLAY PANEL - 2 OZ Spray Label

Americaine® 
Benzocaine
Topical Anesthetic Spray
NET WT. 2 OZ (57 G)

INGREDIENTS AND APPEARANCE

AMERICAINE 
benzocaine aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-378
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	11.4 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
ISOBUTANE (UNII: BXR49TP611)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPANE (UNII: T75W9911L6)

Product Characteristics
Color	WHITE (clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-378-02	57 g in 1 CAN; Type 0: Not a Combination Product	07/14/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	07/14/2009

Labeler - Insight Pharmaceuticals LLC (055665422)