Americaine: Package Insert and Label Information

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.

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)
(click image for full-size original)
AMERICAINE
benzocaine aerosol, spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-378
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 11.4 g in 57 g
Inactive Ingredients
Ingredient Name Strength
ISOBUTANE
POLYETHYLENE GLYCOL 300
PROPANE
Product Characteristics
Color WHITE (clear) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-378-02 57 g in 1 CAN None
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)

Revised: 01/2020 Insight Pharmaceuticals LLC

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