Smartpractice Topical Anesthetic Gel
FDA Label NDC 69521-031

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Smarthealth, Inc. (dba Smartpractice) for the product Smartpractice Topical Anesthetic Gel (NDC 69521-031). 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 description, indications, contraindications, warnings, precautions, dosage and administration, storage, distributed by, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Description

→ Indications

→ Contraindications

→ Warnings

→ Precautions

→ Dosage And Administration

→ Storage

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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.