FDA Label for Benzo-jel Pina Colada
View Indications, Usage & Precautions
Benzo-jel Pina Colada Product Label
The following document was submitted to the FDA by the labeler of this product Henry Schein 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.
Ingredients
Each gram of Benzo-Jel™ 20% benzocaine gel contains between 180-220 mg benzocaine USP, in a water soluble base of PEG 3350 USP, PEG 400 USP, flavor, Sodium Saccharin USP.
Usual Dosage
For oral mucosal use only as directed by a dentist.
Warning
Keep out of the reach of children. Store at controlled room temperature 59°-86°F (15°-30°C). Do not use on people with known allergies to benzocaine and PABA compounds.
Caution
Federal law (USA) prohibits dispensing without prescription.
Other
Reorder #101-3099
1731024LA (R 5/19/10)
NDC# 0404-3099-01
Distributed By:
HENRY SCHEIN INC.
Melville, NY 11747 Made in USA
Principal Display Panel - 29.6 Ml Jar Label
HENRY SCHEIN®
BENZO-JEL™
TOPICAL ANESTHETIC GEL
Piña Colada Flavor
20% Benzocaine
FOR PROFESSIONAL USE ONLY
1 FL. OZ. (29.6 mL)
* Please review the disclaimer below.