FDA Label for Topical Anesthetic Bubble Gum
View Indications, Usage & Precautions
Topical Anesthetic Bubble Gum Product Label
The following document was submitted to the FDA by the labeler of this product Safco Dental Supply Co.. 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.
Ingredients
Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine U.S.P., in a water soluble base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin U.S.P., and D&C Red #28.
Usual Dosage
For oral mucosal use only as directed by a dentist.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Do not use on people with known allergies to benzocaine and PABA compounds.
Storage And Handling
Store at controlled room temperature 59-86°F (15-30°C).
Caution
Federal law prohibits dispensing without a prescription.
Other
Distributed by:
Safco Dental Supply Co.
Buffalo Grove, IL 60089
800-621-2178
www.safcodental.com
Principal Display Panel - Jar Label
SAFCO
SensiCaine
Topical Anesthetic Gel
Bubble Gum Flavor
Contains 20% Benzocaine
For Professional Use Only
1 oz. (34 g)
* Please review the disclaimer below.