TOPEX PINA COLADA- benzocaine gel, dentifrice
TOPEX CHERRY- benzocaine gel, dentifrice
TOPEX MINT- benzocaine gel, dentifrice
TOPEX BUBBLE GUM- benzocaine gel, dentifrice
TOPEX STRAWBERRY- benzocaine gel, dentifrice
TOPEX RASPBERRY- benzocaine gel, dentifrice
Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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DIRECTIONS FOR USE
Gel – 1oz/30mL
AD31001 Cherry
AD31002 Mint
AD31004 Pina Colada
AD31005 Bubble-Num
AD31006 Strawberry
AD31007 Razzberry
Gel – 100g jar
AD31064 Cherry
AD31964 Mint
AD31067 Pina Colada
AD31068 Bubble-Num
For dental use only.
Rx only.
1. INDICATIONS AND USAGE
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. Apply as required.
2. DOSAGE AND ADMINISTRATION
- 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
- Tightly re-cap the jar after each use.
3. DOSAGE FORMS AND STRENGTHS
Each gram of Topex Topical Anesthetic Gel contains between 180-220 mg benzocaine in a flavored base.
4. CONTRAINDICATIONS
Do not use onindividuals with a known sensitivity to benzocaine or PABA.
5. WARNINGS AND PRECAUTIONS
METHEMOGLOBINEMIA WARNING:
Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if the patient in your care develops:
- pale, gray or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Not for use in children under 2 years of age
Keep out of reach of children
For professional dental use only
Take care not to contaminate the jar by reintroducing a used cotton applicator into the jar
6. OVERDOSAGE
In case of overdose, get medical help or contact a Poison Control Center right away.
7. DESCRIPTION
Flavored 20% benzocaine gel or liquid for topical mucosal anesthesia.
8. HOW SUPPLIED / STORAGE AND HANDLING
Topex 20% benzocaine gel is supplied in multiple use containers.
Store between 59°-86°F (15°-30°C). Protect from freezing.
MANUFACTURED FOR
Sultan Healthcare
1301 Smile Way • York, PA 17404 • USA
Toll Free: 800-637-8582 • Phone: 201-871-1232
Fax: 201-871-0321 • www.sultanhealthcare.com
Made in the USA
0031001DF, R4-072017
PRINCIPAL DISPLAY PANEL - Cherry 34 Gram
PRINCIPAL DISPLAY PANEL - Mint 34 gram
PRINCIPAL DISPLAY PANEL - Pina Colada 34 gram
PRINCIPAL DISPLAY PANEL - Bubble Num 34 gram
PRINCIPAL DISPLAY PANEL - Strawberry 34 gram
PRINCIPAL DISPLAY PANEL - Razzberry 34 gram
PRINCIPAL DISPLAY PANEL - Cherry 100 gram
PRINCIPAL DISPLAY PANEL - Mint 100 gram
PRINCIPAL DISPLAY PANEL - Pina Colada 100 gram
PRINCIPAL DISPLAY PANEL - Bubble Num 100 gram
Dentsply LLC. Professional Division Trading as "Sultan Healthcare"