FDA Label for Americaine
View Indications, Usage & Precautions
Americaine Product Label
The following document was submitted to the FDA by the labeler of this product Insight Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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)
* Please review the disclaimer below.