1. Home
  2. Labeler Index
  3. Dentsply Caulk
  4. 10216-3091
  5. Label Information: Topex Pina Colada

FDA Label for Topex Pina Colada

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. 1. DESCRIPTION
    3. 2. INDICATIONS
    4. 3. CONTRAINDICATIONS
    5. 4. WARNINGS
    6. 5. PRECAUTIONS
    7. 6. DOSAGE AND ADMINISTRATION
    8. 7. STORAGE
    9. PRINCIPAL DISPLAY PANEL - 100 GRAM JAR LABEL

Topex Pina Colada Product Label

The following document was submitted to the FDA by the labeler of this product Dentsply Caulk. 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.

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.

7. Storage



Store between 59°-86°F (15°-30°C). Protect from freezing.


Principal Display Panel - 100 Gram Jar Label



NPN 00638358

TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)

CHERRY

Net Content 100g

PRINCIPAL DISPLAY PANEL - 100 gram Jar Label - topex 01

PRINCIPAL DISPLAY PANEL - 100 gram Jar Label - topex 01

NPN 00638358

TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)

MINT

Net Content 100g

NPN 00638358

TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)

PIÑA COLADA

Net Content 100g

NPN 00638358

TOPEX®
TOPICAL
ANESTHETIC
GEL
(Benzocaine 20%)

BUBBLE NUM®

Net Content 100g


* Please review the disclaimer below.