Topex
FDA Label NDC 10216-3071

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dentsply Caulk for the product Topex (NDC 10216-3071). 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 other, 1. description, 2. indications, 3. contraindications, 4. warnings, 5. precautions, 6. dosage and administration, 7. storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ 1. Description

→ 2. Indications

→ 3. Contraindications

→ 4. Warnings

→ 5. Precautions

→ 6. Dosage And Administration

→ 7. Storage

→ Principal Display Panel - 100 Gram Jar Label

Other

DIRECTIONS FOR USE

Gel – 1oz/30mL
REF AD31001 Cherry
REF AD31002 Mint
REF AD31003 Banana
REF AD31004 Pina Colada
REF AD31005 Bubble-Num
REF AD31006 Strawberry
REF AD31007 Razzberry

Gel – 100g jar
REF AD31064 Cherry
REF AD31964 Mint
REF AD31067 Pina Colada
REF AD31068 Bubble-Num

Liquid – 1oz/30mL
REF AD31011 Cherry
REF AD31012 Mint
REF AD31014 Pina Colada USP – 2oz/57g

NPN Number: 00638358
For dental use only.
USA: Rx only.

SultanHealthcare
411 Hackensack Avenue, 9th Floor, Hackensack, NJ 07601
Toll Free: 800-637-8582 • Phone: 201-871-1232
Fax: 201-871-0321 • www.sultanhealthcare.com

Made in the USA
Form #0030502DF (R 7/22/09)

1. Description

Flavored 20% benzocaine gel or liquid for topical mucosal anesthesia.

2. Indications

Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intraoral radiographs.

3. Contraindications

Should not be used with individuals with a known sensitivity to benzocaine or PABA.

4. Warnings

Keep out of reach of children. For professional dental use only.

5. Precautions

Topex 20% benzocaine gels and liquids are supplied in multiple use containers. Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle.

6. Dosage And Administration

Each gram of Topex 20% benzocaine gel or liquid contains between 180-220mg benzocaine in a flavored base.
Using a new cotton applicator, apply a small amount of gel to the mucosa to achieve topical anesthesia. Do not reintroduce the cotton applicator into the bottle.
For topical tissue anesthesia during scaling procedures, dispense a small amount of Topex gel or liquid into a dappen dish, then coat the scaler with the product prior to use.
Tightly re-cap the jar after each use.