Topex ® Topical Anesthetic Gel 20% Benzocaine

SPL UNCLASSIFIED SECTION

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:

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

• pale, gray or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

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