FDA Label for Gelato Topical Anesthetic
View Indications, Usage & Precautions
Gelato Topical Anesthetic Product Label
The following document was submitted to the FDA by the labeler of this product Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products 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%
Purpose:
Oral Anesthetic
Uses:
- For the temporary relief of occasional minor irritation and pain associated with canker sores and minor dental procedures.
- For Professional Use Only.
Warnings
Flammable. Do not use near fire or flame. Avoid smoking during use.
Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Stop use and ask a doctor if you experience any of the following symptoms:
- weakness
- confusion
- headache
- difficulty breathing
- pale, grey or blue colored skin as these may be signs of methemoglobinemia, a rare disorder, which may appear up to two hours after use.
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. Avoid spraying in eyes
Dosage
A single metered spray dispenses 50 mg of Gelato Topical Anesthetic. Use only as directed by a dentist.
Other Information
Store at room temperature. Do not store above 120°F (49°C). Dispose of in a manner consistent with local regulations.
Inactive Ingredients
Ethyl Alcohol, Flavor, Polyethylene Glycol, Sodium Saccharin, Hydrocarbon Propellant (Isobutane and propane)
Questions Or Comments?
1-800-333-3131
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