Drugplain

Burkhart .116 g/120g

Stannous Fluoride · GEL · Burkhart Dental Supply Inc

1 Recall on Record
Plain English

Stannous Fluoride gel is a dental product applied topically to help prevent tooth decay and strengthen tooth enamel. This over-the-counter gel contains fluoride and is used as part of a regular oral hygiene routine.

Key Facts

Brand Name
Burkhart
Generic Name
Stannous Fluoride
NDC Code (Product)
43498-251
Manufacturer
Burkhart Dental Supply Inc
Strength
.116 g/120g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Application #
M022
Marketing Start
01/05/2013

Recall History

1 Recall on Record
Class II11/14/2024

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.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea208 reports
pyrexia204 reports
fatigue193 reports
vomiting188 reports
pain186 reports
nasopharyngitis167 reports
weight decreased165 reports
peripheral swelling164 reports
weight increased164 reports
urticaria160 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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?

Stannous Fluoride gel is a dental product applied topically to help prevent tooth decay and strengthen tooth enamel. This over-the-counter gel contains fluoride and is used as part of a regular oral hygiene routine.

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 Stannous Fluoride. There are 12 other brand versions of Stannous Fluoride.

What is the NDC code for Burkhart .116 g/120g?

The NDC (National Drug Code) for Burkhart .116 g/120g is 43498-251, listed by Burkhart Dental Supply Inc.

Product NDC

43498-251

Package NDC

43498-251-04

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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)