FDA Label for Smartpractice Topical Anesthetic Gel Cherry
View Indications, Usage & Precautions
- DESCRIPTION
- INDICATIONS
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- DOSAGE AND ADMINISTRATION
- STORAGE
- DISTRIBUTED BY
- PRINCIPAL DISPLAY PANEL - CHERRY
- PRICIPAL DISPLAY PANEL - MINT
- PRINCIPAL DISPLAY PANEL - PINA COLADA
- PRINCIPAL DISPL;AY PANEL - BUBBLE GUM
- PRINCIPAL DISPLAY PANEL - STRAWBERRY
- PRINCIPAL DISPLAY PANEL - RASPBERRY
Smartpractice Topical Anesthetic Gel Cherry Product Label
The following document was submitted to the FDA by the labeler of this product Smarthealth, Inc. (dba Smartpractice). 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.
Description
Flavored 20% benzocaine gel or liquid for topical mucosal anesthesia.
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 intra- oral radiographs.
Contraindications
Should not be used with individuals with a known sensitivity to benzocaine or PABA.
Warnings
Keep out of reach of children. For professional dental use only.
Precautions
SmartPractice 20% benzocaine gels are supplied in multiple use containers. Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle.
Dosage And Administration
1. Each gram of benzocaine gel between 180-220mg benzocaine in a flavored base.
2. 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.
3. For topical tissue anesthesia during scaling procedures, dispense a small amount of gel into a dappen dish, then coat the scaler with the product prior to use.
4. Tightly re-cap the jar after each use.
Storage
Store between 59°-86°F (15°-30°C). Protect from freezing.
Distributed By
distributed by:
SmartPractice
3400 east mcdowell rd
phoenix, AZ 85008
Made in USA.
Principal Display Panel - Cherry
Pricipal Display Panel - Mint
Principal Display Panel - Pina Colada
Principal Displ;Ay Panel - Bubble Gum
Principal Display Panel - Strawberry
Principal Display Panel - Raspberry
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