Burkhart 5.6 g/454g
Sodium Fluoride · GEL · Burkhart Dental Supply Inc
Burkhart is a prescription dental gel containing sodium fluoride that helps prevent tooth decay and strengthen tooth enamel. It is applied directly to the teeth by a dentist or dental professional.
Key Facts
- Brand Name
- Burkhart
- Generic Name
- Sodium Fluoride
- NDC Code (Product)
43498-106- Manufacturer
- Burkhart Dental Supply Inc
- Strength
- 5.6 g/454g
- Dosage Form
- GEL
- Route
- DENTAL
- Marketing Status
- Marketing Start
- 12/14/2012
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
Uses: Home Care is a stable, water-free fluoride gel for home use. Aids in the prevention of dental decay.
Dosage & Administration
Directions: Adults and children 6 years of age and older: Twist off cap and remove foil seal. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: consult a dentist or doctor.
Warnings
Warnings: If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
Frequently Asked Questions
What is Burkhart used for?
Burkhart is a prescription dental gel containing sodium fluoride that helps prevent tooth decay and strengthen tooth enamel. It is applied directly to the teeth by a dentist or dental professional.
Is Burkhart a controlled substance?
Burkhart is not classified as a controlled substance by the DEA.
What is the generic name for Burkhart?
The generic name for Burkhart is Sodium Fluoride. There are 12 other brand versions of Sodium Fluoride.
What is the NDC code for Burkhart 5.6 g/454g?
The NDC (National Drug Code) for Burkhart 5.6 g/454g is 43498-106, listed by Burkhart Dental Supply 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)