FDA Label for Sensicaine Tm Extra Topical Anesthetic
View Indications, Usage & Precautions
Sensicaine Tm Extra Topical Anesthetic Product Label
The following document was submitted to the FDA by the labeler of this product Safco Dental Supply Co.. 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.
Active Ingridients (In Each Gram)
Benzocaine 200 mg
Purpose
Oral Anesthetic
Use
For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Warnings
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood.This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child 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
Allergy alert: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
Sore throat warning:If sore throat is severe,persists for more than 2 days,is accompanied or followed by fever, headache, rash, swelling, nausea,or vomiting, consult a doctor promptly.If sore mouth symptoms do not improve in 7 days, or if irritation,pain, or redness persist or worsen, see your dentist or doctor promptly.
Do Not Use
- for teething
- in children under 2 years of age
Directions
- adults and children 2 years of age and older: apply only amount needed to the oral mucosa to prevent or relieve pain
- children under 2 years of age: do not use
Other Information
- Store at 59 - 86°F (15 - 30°C).
- Protect from freezing.
Inactive Ingredients
flavoring, PEG 3350, PEG 400, sucralose and FD&C Blue #1, FD&C Red #40, D&C Green #5, FD&C Yellow #5 as a color additive.
Questions Or Comments?
800-621-2178
www.safcodental.com
Principal Display Panel - Jar Label
SAFCO
SensiCaineTM Extra
Topical Anesthetic Gel
Contains 20% Benzocaine
Raspberry Flavor
For Professional Use Only
1 oz. (34 g)
* Please review the disclaimer below.
