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, and FD&C Red #28.
Benzo-jel
FDA Label NDC 0404-9442
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein Inc for the product Benzo-jel (NDC 0404-9442). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding ingredients, usual dosage, warning, storage and handling, caution, other, principal display panel - 29.6 ml jar label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Usual Dosage
For oral mucosal use only as directed by a dentist.
Warning
Keep out of the reach of children.
Storage And Handling
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 #101-9442
1731025LA (R 5/19/10)
NDC# 0404-9442-01
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
Bubble Gum
20% Benzocaine
FOR PROFESSIONAL USE ONLY
1 FL. OZ. (29.6 mL)
Principal Display Panel (29.6 mL Jar Label)
* Please review the disclaimer below.
