Label: AMERICAINE- benzocaine aerosol, spray

  • NDC Code(s): 63736-378-02
  • Packager: Insight Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 14, 2020

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  • 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)

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

  • INGREDIENTS AND APPEARANCE
    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)
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