AMERICAINE- benzocaine aerosol, spray 
Insight Pharmaceuticals LLC

----------

Americaine Topical Spray

Americaine® 
Benzocaine 

Topical Anesthetic Spray

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Topical Anesthetic

Uses

temporarily relieves pain and itching associated with:

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

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)

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

AMERICAINE 
benzocaine aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-378
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE11.4 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
ISOBUTANE (UNII: BXR49TP611)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
PROPANE (UNII: T75W9911L6)  
Product Characteristics
Colorwhite (clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-378-0257 g in 1 CAN; Type 0: Not a Combination Product07/14/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/14/2009
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 10/2024
Document Id: 90f42b28-e52c-4fa9-a341-cd2ca7d22272
Set id: 4fd14452-0285-40c4-b835-36935c2056b2
Version: 7
Effective Time: 20241025
 
Insight Pharmaceuticals LLC