Benzo-jel™

Benzo-jel™
SPL v1
SPL
SPL Set ID 07d8c4da-2c28-4aae-a129-03aae15b2991
Route
DENTAL
Published
Effective Date 2010-08-27
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (220 mg)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 1963-02-19

Description

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, FD&C Red #28, FD&C Red #40 and FD&C Blue #1.


Medication Information

Description

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, FD&C Red #28, FD&C Red #40 and FD&C Blue #1.

Section 42229-5

Do not use on people with known allergies to benzocaine and PABA compounds.

Section 44425-7

Store at controlled room temperature 59°-86°F (15°-30°C).

Caution

Federal law (USA) prohibits dispensing without prescription.

Warning

Keep out of the reach of children.

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, FD&C Red #28, FD&C Red #40 and FD&C Blue #1.

Usual Dosage

For oral mucosal use only as directed by a dentist.

Principal Display Panel 29.6 Ml Bottle Label

HENRY SCHEIN®

BENZO-JEL™

TOPICAL ANESTHETIC GEL

Raspberry Flavor

20% Benzocaine

FOR PROFESSIONAL USE ONLY

1 FL. OZ. (29.6 mL)


Structured Label Content

Section 42229-5 (42229-5)

Do not use on people with known allergies to benzocaine and PABA compounds.

Section 44425-7 (44425-7)

Store at controlled room temperature 59°-86°F (15°-30°C).

Caution (CAUTION)

Federal law (USA) prohibits dispensing without prescription.

Warning (WARNING)

Keep out of the reach of children.

Ingredients (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, FD&C Red #28, FD&C Red #40 and FD&C Blue #1.

Usual Dosage (USUAL DOSAGE)

For oral mucosal use only as directed by a dentist.

Principal Display Panel 29.6 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label)

HENRY SCHEIN®

BENZO-JEL™

TOPICAL ANESTHETIC GEL

Raspberry Flavor

20% Benzocaine

FOR PROFESSIONAL USE ONLY

1 FL. OZ. (29.6 mL)


Advanced Ingredient Data


Raw Label Data

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