Drugplain

PreviDent 5000 Enamel Protect 57.5 mg/mL

SODIUM FLUORIDE and POTASSIUM NITRATE · GEL, DENTIFRICE · Colgate Oral Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage
Plain English

PreviDent 5000 Enamel Protect is a gel, dentifrice containing sodium fluoride and potassium nitrate at 57.5 mg/mL, taken dental. Manufactured by Colgate Oral Pharmaceuticals, Inc..

Key Facts

Brand Name
PreviDent 5000 Enamel Protect
Generic Name
SODIUM FLUORIDE and POTASSIUM NITRATE
NDC Code (Product)
0126-0022
Manufacturer
Colgate Oral Pharmaceuticals, Inc.
Strength
57.5 mg/mL
Dosage Form
GEL, DENTIFRICE
Route
DENTAL
Marketing Status
Marketing Start
03/30/2011

Recall History

No Recall History

Side Effects Reported to FDA

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

atrial fibrillation3 reports
blister2 reports
constipation2 reports
nausea2 reports
plasma cell myeloma2 reports
pneumonia2 reports
vomiting2 reports
weight decreased2 reports
accident1 reports
acute kidney injury1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 PreviDent ® 5000 Enamel Protect brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where 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: Adults and children 12 years of age and older: Apply at least a 1 inch strip of PreviDent ® 5000 Enamel Protect onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician.

Warnings

WARNINGS Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician. Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Contraindications

CONTRAINDICATIONS Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.

Adverse Reactions

ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported.

Frequently Asked Questions

What is PreviDent 5000 Enamel Protect used for?

PreviDent 5000 Enamel Protect contains SODIUM FLUORIDE and POTASSIUM NITRATE. It is a gel, dentifrice taken dental. Consult your doctor for specific uses.

Is PreviDent 5000 Enamel Protect a controlled substance?

PreviDent 5000 Enamel Protect is not classified as a controlled substance by the DEA.

What is the generic name for PreviDent 5000 Enamel Protect?

The generic name for PreviDent 5000 Enamel Protect is SODIUM FLUORIDE and POTASSIUM NITRATE. There are 9 other brand versions of SODIUM FLUORIDE and POTASSIUM NITRATE.

What is the NDC code for PreviDent 5000 Enamel Protect 57.5 mg/mL?

The NDC (National Drug Code) for PreviDent 5000 Enamel Protect 57.5 mg/mL is 0126-0022, listed by Colgate Oral Pharmaceuticals, Inc..

Product NDC

0126-0022

Package NDC

0126-0022-92

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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