TOPEX PINA COLADA- benzocaine gel, dentifrice TOPEX CHERRY- benzocaine gel, dentifrice TOPEX MINT- benzocaine gel, dentifrice

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)

Available from:

Dentsply LLC. Professional Division Trading as "Sultan Healthcare"

INN (International Name):

BENZOCAINE

Composition:

BENZOCAINE 220 mg in 1 g

Administration route:

DENTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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 intraoral radiographs. Apply as required. Do not use onindividuals with a known sensitivity to benzocaine or PABA.

Product summary:

Topex 20% benzocaine gel is supplied in multiple use containers. Store between 59°-86°F (15°-30°C). Protect from freezing.

Authorization status:

unapproved drug other

Summary of Product characteristics

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._
----------
TOPEX TOPICAL ANESTHETIC GEL
20% BENZOCAINE
_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
1. 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
2. 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