FDA Label for Opahl
View Indications, Usage & Precautions
Opahl Product Label
The following document was submitted to the FDA by the labeler of this product Dharma Research, Inc.. 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%......................................................Oral Anesthetic
Uses
For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.
Warnings
- Keep out of reach of children
- If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
- Do not use if you have a history of allergy to local anesthetic such a procaine, butacaine, benzocaine or other "caine" anesthetics.
- Flammable. Do not use near fire or flame. Avoid smoking during use.
- Avoid spraying in eyes.
Dosage
A single metered spray dispenses 50mg of Opahl-S Topical Anesthetic.
Directions
- Do not exceed recommended dosage
- Firmly insert extension tube into spray can valve and ensure it fits securely into the actuator opening
- position the extension tube 1-2 inches from the affected area.
- Spray 1/2 second (press and immediately release the actuator)
- Anesthesia is accomplished in approximately 20 seconds.
Other Information
- Do not store at room temperature above 49oC (120oF)
- For professional use only. Federal US Law prohibits dispensing without a prescription
Inactive Ingredients
Denatured Alcohol, Flavor, Polyethylene Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and Propane)
Label
* Please review the disclaimer below.