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Americaine

Insight Pharmaceuticals

Americaine Benzocaine Topical Anesthetic Spray


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Benzocaine 20%

Purpose

Topical Anesthetic

Americaine 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 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 or visit our website at www.insightpharma.com

Distributed by:
INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - 2 OZ Spray Label

Hospital
Formula

Americaine®
Benzocaine
Topical Anesthetic Spray
Shake Well Before Use

Maximum Strength
20% Benzocaine

Stops the pain and itch fast.
For minor cuts, scrapes,
burns and sunburns.

NET WT. 2 OZ (57 G)

Americaine

Americaine

Benzocaine AEROSOL, SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63736-378
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 11.4 g

Inactive Ingredients

Ingredient Name Strength
isobutane
POLYETHYLENE GLYCOL 300
propane

Product Characteristics

Color
WHITE (clear)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63736-378-02 57 in 1 CAN

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2009-07-14


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Be sure to consult your doctor before taking any medication!
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