Benzo-jel
FDA Label NDC 0404-0741

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 0404-0741). 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 storage: store benzo-jel at controlled room temperature, between 59 and 86°f (15 and 30°c)., reorder #’s:strawberry (#112-7286)bubble gum (#112-7287)mint (#112-7288) ndc # 0404-0742-01 (strawberry) ndc # 0404-0743-01 (bubble gum) ndc # 0404-0741-01 (mint), package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Storage: Store Benzo-Jel At Controlled Room Temperature, Between 59 And 86°F (15 And 30°C).

Caution: Federal law (USA) prohibits dispensing without a prescription.
Ingredients:
Active: Each gram of 20% Benzocaine gel contains 200mg of Benzocaine USP
Inactive:
Strawberry: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavor, FD&C Red # 40
Bubble Gum: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavor, D&C Red # 28
Mint: Polyethylene Glycol 400, Polyethylene Glycol 3350, Sucralose, flavors, D&C Green # 5

For professional use only.

Reorder #’S:Strawberry (#112-7286)Bubble Gum (#112-7287)Mint (#112-7288) Ndc # 0404-0742-01 (Strawberry) Ndc # 0404-0743-01 (Bubble Gum) Ndc # 0404-0741-01 (Mint)


Distributed by (in US only):
HENRY SCHEIN, INC.
135 DURYEA ROAD
MELVILLE, NY 11747 USA
MADE IN USA
246001      Rev Date: 05/2015

Package Label

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