Americaine Aerosol, Spray
FDA Label NDC 63736-378

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Americaine (NDC 63736-378). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, flammability warning, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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® Benzocainetopical Anesthetic Spraynet Wt. 2 Oz (57 G) (Americaine Topical Spray 01)

Americaine® Benzocainetopical Anesthetic Spraynet Wt. 2 Oz (57 G) (Americaine Topical Spray 01)

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