FLUORIDEX 5 mg/g

Sodium Fluoride · PASTE, DENTIFRICE · DEN-MAT HOLDINGS, LLC.

No Recall HistoryCurrently in Shortage

Plain English

FLUORIDEX is a paste, dentifrice containing sodium fluoride at 5 mg/g, taken dental. Manufactured by DEN-MAT HOLDINGS, LLC..

Key Facts

Brand Name: FLUORIDEX
Generic Name: Sodium Fluoride
NDC Code (Product): 59883-020
Manufacturer: DEN-MAT HOLDINGS, LLC.
Strength: 5 mg/g
Dosage Form: PASTE, DENTIFRICE
Route: DENTAL
Marketing Status
Marketing Start: 01/03/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

pyrexia170 reports

fatigue160 reports

nausea159 reports

vomiting157 reports

weight increased156 reports

pain155 reports

nasopharyngitis153 reports

peripheral swelling146 reports

type 2 diabetes mellitus145 reports

pneumonia144 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use Aids in the prevention of dental cavities

Dosage & Administration

Directions Adults and children 6 years of age and older: Do not use before mixing with water Use once a day after brushing your teeth with a toothpaste Separate provided graduated cup from the mixing cap Fill graduated cup to 1/8oz. fill line with Fluoridex Daily Renewal Oral Rinse Concentrate Add warm water to 1 oz. fill line Place the mixing cap onto the filled cap until it snaps closed Shake thoroughly then remove mixing cap Use immediately after preparing the rinse Vigorously swish with half of the prepared solution between your teeth for 1 minute and then spit out Do not swallow the rinse Repeat the procedure with the remaining half of the prepared solution Do not eat or drink for 30 minutes after rinising Instruct children under 12 years of age in good rinsing habits (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

Do not swallow the rinse

Frequently Asked Questions

What is FLUORIDEX used for?

FLUORIDEX contains Sodium Fluoride. It is a paste, dentifrice taken dental. Consult your doctor for specific uses.

Is FLUORIDEX a controlled substance?

FLUORIDEX is not classified as a controlled substance by the DEA.

What is the generic name for FLUORIDEX?

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

What is the NDC code for FLUORIDEX 5 mg/g?

The NDC (National Drug Code) for FLUORIDEX 5 mg/g is 59883-020, listed by DEN-MAT HOLDINGS, LLC..

Product NDC

59883-020

Package NDC

59883-020-04

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)