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Topical Anesthetic Gel - 20% Benzocaine


SPL UNCLASSIFIED SECTION

Gel – 1oz/34g2731001 Cherry2731002 Mint2731004 Pina Colada2731005 Bubble Gum2731006 Strawberry2731007 Raspberry

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 intra- oral radiographs.


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 STRENGTH

Each gram of 20% Benzocaine Gel contains between 180-220 mg benzocaine in a flavored base.


4. CONTRAINDICATIONS

Should not be used with individuals 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

6. OVERDOSAGE

In case of overdose, get medical help or contact a Poison Control Center right away.


7. DESCRIPTION

Flavored 20% benzocaine gel for topical mucosa anesthesia


8. HOW SUPPLIED/STORAGE AND HANDLING

20% benzocaine gel is supplied in multiple use containers


STORAGE AND HANDLING SECTION

Store between 59°-86°F (15°-30°C). Protect from freezing.


SPL UNCLASSIFIED SECTION

For more information call NDC at 1-800-929-4232 Manufactured for NDC Nashville, TN 37217Made in the USA2731001DF, R1-120116