FDA Label for Comfortcaine Topical Anesthetic
View Indications, Usage & Precautions
Comfortcaine Topical Anesthetic Product Label
The following document was submitted to the FDA by the labeler of this product Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products 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.
Active Ingredients
Benzocaine 200mg (in each g)
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 the 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
- for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain or redness persists or worsens; or if swelling, rash or fever develops, see your physician promptly.
- for teething
- in children under 2 years of age
Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
Do not use
When using this product Avoid contact with eyes. If contact occurs, flush with water.
Do not exceed recommended dosage. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a physician before use.
Directions
- Apply only amount needed to the oral mucosa to prevent or relieve pain.
- children under 2 years of age: do not use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Information
Store at 59°-86°F (15°-30°C). Protect from freezing.
Inactive Ingredients
Flavoring, PEG 3350, PEG 400, sodium saccharin, water. May contain blue #1, green #3, green #5, red #3, red #28, red #40, yellow#5 (tartrazine), yellow #6, as a color additive.
Questions Or Comments?
1-800-333-3131 or 856-663-4700
keystoneindustries.com
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