AMERICAINE- benzocaine aerosol, spray 
Insight Pharmaceuticals LLC

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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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 NOT FINALpart34807/14/2009
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 1/2020
Document Id: a964404f-73c4-4fd2-abb3-c78ac8273255
Set id: 4fd14452-0285-40c4-b835-36935c2056b2
Version: 6
Effective Time: 20200114
 
Insight Pharmaceuticals LLC