FDA Label for Topical Anesthetic
View Indications, Usage & Precautions
- OTHER
- 1. INDICATIONS AND USAGE
- 2. DOSAGE AND ADMINISTRATION
- 3. DOSAGE FORMS AND STRENGTH
- 4. CONTRAINDICATIONS
- METHEMOGLOBINEMIA WARNING
- 6. OVERDOSAGE
- 7. DESCRIPTION
- 8. HOW SUPPLIED/STORAGE AND HANDLING
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL - 34 G JAR LABEL - CHERRY
- PRINCIPAL DISPLAY PANEL - 34 G JAR LABEL - MINT
- PRINCIPAL DISPLAY PANEL - 34 G JAR LABEL - PIñA COLADA
- PRINCIPAL DISPLAY PANEL - 34 G JAR LABEL - BUBBLE GUM
- PRINCIPAL DISPLAY PANEL - 34 G JAR LABEL - STRAWBERRY
- PRINCIPAL DISPLAY PANEL - 34 G JAR LABEL - RASPBERRY
Topical Anesthetic Product Label
The following document was submitted to the FDA by the labeler of this product Ndc, Inc.. 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.
Other
Gel – 1oz/34g
2731001 Cherry
2731002 Mint
2731004 Pina Colada
2731005 Bubble Gum
2731006 Strawberry
2731007 Raspberry
For dental use only
Rx only
For more information call NDC at 1-800-929-4232
Manufactured for NDC Nashville, TN 37217
Made in the USA
2731001DF, R1-120116
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.
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 out of reach of children❖ For professional dental use only❖ Take care not to contaminate the bottle by reintroducing a used cotton applicator into the bottle
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
Store between 59°-86°F (15°-30°C). Protect from freezing.
Principal Display Panel - 34 G Jar Label - Cherry
Topical Anesthetic Gel
(20% Benzocaine)
For Professional Use Only
Cherry
Q®
Quala
DENTAL PRODUCTS
2731001
Quala-ty for the
caring professional
Principal Display Panel - 34 G Jar Label - Mint
Topical Anesthetic Gel
(20% Benzocaine)
For Professional Use Only
Mint
Q®
Quala
DENTAL PRODUCTS
2731002
Quala-ty for the
caring professional
Principal Display Panel - 34 G Jar Label - Piña Colada
Topical Anesthetic Gel
(20% Benzocaine)
For Professional Use Only
Piña Colada
Q®
Quala
DENTAL PRODUCTS
2731004
Quala-ty for the
caring professional
Principal Display Panel - 34 G Jar Label - Bubble Gum
Topical Anesthetic Gel
(20% Benzocaine)
For Professional Use Only
Bubble Gum
Q®
Quala
DENTAL PRODUCTS
2731005
Quala-ty for the
caring professional
Principal Display Panel - 34 G Jar Label - Strawberry
Topical Anesthetic Gel
(20% Benzocaine)
For Professional Use Only
Strawberry
Q®
Quala
DENTAL PRODUCTS
2731006
Quala-ty for the
caring professional
Principal Display Panel - 34 G Jar Label - Raspberry
Topical Anesthetic Gel
(20% Benzocaine)
For Professional Use Only
Raspberry
Q®
Quala
DENTAL PRODUCTS
2731007
Quala-ty for the
caring professional
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