Quala Topical Anesthetic Gel 200 mg/g
Benzocaine · GEL · Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Quala is a topical anesthetic gel containing benzocaine that is applied directly to the gums or mouth to numb pain and discomfort from dental procedures, teething, or oral irritation. This product is available over-the-counter without a prescription.
Key Facts
- Brand Name
- Quala Topical Anesthetic Gel
- Generic Name
- Benzocaine
- NDC Code (Product)
68400-478- Manufacturer
- Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
- Strength
- 200 mg/g
- Dosage Form
- GEL
- Route
- DENTAL
- Marketing Status
- Application #
- M022
- Drug Class
- Standardized Chemical Allergen [EPC]
- Marketing Start
- 02/03/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use For oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Dosage & Administration
Directions Apply only amount needed to the oral mucosa to prevent or relieve pain. children under 2 years of age: do not use
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 phys…
Frequently Asked Questions
What is Quala Topical Anesthetic Gel used for?
Quala is a topical anesthetic gel containing benzocaine that is applied directly to the gums or mouth to numb pain and discomfort from dental procedures, teething, or oral irritation. This product is available over-the-counter without a prescription.
Is Quala Topical Anesthetic Gel a controlled substance?
Quala Topical Anesthetic Gel is not classified as a controlled substance by the DEA.
What is the generic name for Quala Topical Anesthetic Gel?
The generic name for Quala Topical Anesthetic Gel is Benzocaine. There are 12 other brand versions of Benzocaine.
What is the NDC code for Quala Topical Anesthetic Gel 200 mg/g?
The NDC (National Drug Code) for Quala Topical Anesthetic Gel 200 mg/g is 68400-478, listed by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)