Burkhart Topical Anesthetic 200 mg/g
Benzocaine · GEL · Burkhart Dental Supply Inc
Burkhart Topical Anesthetic is an over-the-counter dental gel containing benzocaine that numbs oral tissues to relieve pain from minor mouth sores, teething, or dental procedures. It works by blocking nerve signals in the area where it is applied.
Key Facts
- Brand Name
- Burkhart Topical Anesthetic
- Generic Name
- Benzocaine
- NDC Code (Product)
43498-313- Manufacturer
- Burkhart Dental Supply Inc
- Strength
- 200 mg/g
- Dosage Form
- GEL
- Route
- DENTAL
- Marketing Status
- Application #
- M022
- Drug Class
- Standardized Chemical Allergen [EPC]
- Marketing Start
- 11/01/2015
Recall History
Keystone Industries
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Side 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 physi…
Frequently Asked Questions
What is Burkhart Topical Anesthetic used for?
Burkhart Topical Anesthetic is an over-the-counter dental gel containing benzocaine that numbs oral tissues to relieve pain from minor mouth sores, teething, or dental procedures. It works by blocking nerve signals in the area where it is applied.
Is Burkhart Topical Anesthetic a controlled substance?
Burkhart Topical Anesthetic is not classified as a controlled substance by the DEA.
What is the generic name for Burkhart Topical Anesthetic?
The generic name for Burkhart Topical Anesthetic is Benzocaine. There are 12 other brand versions of Benzocaine.
What is the NDC code for Burkhart Topical Anesthetic 200 mg/g?
The NDC (National Drug Code) for Burkhart Topical Anesthetic 200 mg/g is 43498-313, listed by Burkhart Dental Supply Inc.
Other Benzocaine Brands
See all →- Oral Pain Relief Gel200 mg/g81417-001
- INTIMALE Benzocaine Delay Gel50 mg/mL81923-369
- Maximum OTC Strength Feminine Anti-Itch Creme5.67 g/28g83324-019
- Cetacaine Anesthetic.028 g/.2g10223-0202
- Topicale180 mg/g10733-166
- VAGISIL Anti-Itch Medicated Creme Maximum Strength200 mg/g11509-4402
- Toothache and Gum Relief Cushions10 g/100g11822-1616
- 4x Medicated Gum Cream.13 g/100g21130-621
- Topcare Maximum Strength20 g/100g36800-443
- Vicks VapoCool Sore Throat5 g/100mL37000-928
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)