Data from FDA - Curated by EPG Health - Last updated 31 December 2017

Indication(s)

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.

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Advisory information

contraindications
4. CONTRAINDICATIONS Do not use onindividuals with a known sensitivity to benzocaine or PABA.

Usage information

Dosing and administration
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.

More information

Category Value
Agency product number U3RSY48JW5
Orphan designation No
Product NDC 0699-7061,0699-7071,0699-7081,0699-3001,0699-7091,0699-7041,0699-7051,0699-7100,0699-7011,0699-7021,0699-7031
Date Last Revised 18-12-2017
Type HUMAN PRESCRIPTION DRUG
Storage and handling 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.
Marketing authorisation holder DSHealthcare