Comfortcaine Topical Anesthetic
Benzocaine · Gel · Dental
Active ingredient
Active Ingredients Benzocaine 200mg (in each g)
Purpose
Purpose Oral Anesthetic
Uses
Use For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Warnings
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 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 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 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.
Keep out of reach of children
Keep out of reach of children.
Directions
Directions Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use
Other information
Other Information Store at 59°-86°F (15°-30°C). Protect from freezing.
Inactive ingredients
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?
Questions or comments? 1-800-333-3131 or 856-663-4700 keystoneindustries.com
Label text from the FDA structured product label by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc (revised Jan 9, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Benzocaine in 3 products
Comfortcaine Topical Anesthetic NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 68400-459 | Benzocaine 200 mg/g Gel | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | OTC MONOGRAPH DRUG |
| 68400-460 | Benzocaine 200 mg/g Gel | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | OTC MONOGRAPH DRUG |
| 68400-461 | Benzocaine 200 mg/g Gel | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Comfortcaine Topical Anesthetic used for?
Use For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Who makes Comfortcaine Topical Anesthetic?
Comfortcaine Topical Anesthetic is listed by 1 labeler in the FDA NDC directory, including Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.