Drugplain

Sodium Fluoride Gel 5 mg/g

Sodium Fluoride · GEL, DENTIFRICE · AvPAK

No Recall HistoryCurrently in Shortage
Plain English

Sodium Fluoride Gel is a prescription-strength fluoride product applied directly to teeth to help prevent tooth decay and strengthen tooth enamel. It comes as a gel that you apply to your teeth as directed by your dentist.

Key Facts

Brand Name
Sodium Fluoride Gel
Generic Name
Sodium Fluoride
NDC Code (Product)
50268-733
Manufacturer
AvPAK
Strength
5 mg/g
Dosage Form
GEL, DENTIFRICE
Route
DENTAL
Marketing Status
Marketing Start
05/09/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain154 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. Sodium Fluoride 1.1% Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Dosage & Administration

DOSAGE AND ADMINISTRATION Follow these instructions unless otherwise instructed by your dental professional: Directions for daily use: 1. After brushing thoroughly with toothpaste, rinse as usual. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth with a toothbrush or mouth trays once daily for at least one minute, preferably at bedtime. 2. After use, adults expectorate gel. For the best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16 years, expectorate gel after use and rinse mouth thoroughly. Precaution: DO NOT SWALLOW.

Warnings

WARNINGS Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel which could cause dental fluorosis. Read directions carefully before using. If using a mouthpiece application, prolonged exposure (longer than 1 minute) may result in oral irritation, such as burning.

Contraindications

CONTRAINDICATIONS Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Adverse Reactions

ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported. You should call your doctor, or dental professional for medical advice about serious adverse events. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is Sodium Fluoride Gel used for?

Sodium Fluoride Gel is a prescription-strength fluoride product applied directly to teeth to help prevent tooth decay and strengthen tooth enamel. It comes as a gel that you apply to your teeth as directed by your dentist.

Is Sodium Fluoride Gel a controlled substance?

Sodium Fluoride Gel is not classified as a controlled substance by the DEA.

What is the generic name for Sodium Fluoride Gel?

The generic name for Sodium Fluoride Gel is Sodium Fluoride. There are 12 other brand versions of Sodium Fluoride.

What is the NDC code for Sodium Fluoride Gel 5 mg/g?

The NDC (National Drug Code) for Sodium Fluoride Gel 5 mg/g is 50268-733, listed by AvPAK.

Product NDC

50268-733

Package NDC

50268-733-56

Other Sodium Brands

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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)