Drugplain

Clinpro 5000 5 mg/g

sodium fluoride · PASTE, DENTIFRICE · Solventum US LLC

1 Recall on RecordCurrently in Shortage
Plain English

Clinpro 5000 is a paste, dentifrice containing sodium fluoride at 5 mg/g, taken oral. Manufactured by Solventum US LLC.

Key Facts

Brand Name
Clinpro 5000
Generic Name
sodium fluoride
NDC Code (Product)
48878-3140
Manufacturer
Solventum US LLC
Strength
5 mg/g
Dosage Form
PASTE, DENTIFRICE
Route
ORAL
Marketing Status
Marketing Start
01/07/2011

Recall History

1 Recall on Record
Class III12/19/2014

3M Company/3m Espe Dental Products

Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

pyrexia170 reports
fatigue160 reports
nausea159 reports
vomiting157 reports
pain155 reports
weight increased155 reports
nasopharyngitis153 reports
type 2 diabetes mellitus147 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Clinpro 5000 Anti-Cavity Toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. Clinpro 5000 Anti-Cavity Toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Use once daily in place of conventional toothpaste unless instructed otherwise by a physician or dentist. • Apply a thin ribbon or pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste using a soft-bristled toothbrush and brush teeth for at least two minutes. • After brushing adults should expectorate. Children 6 to 16 years of age should expectorate and rinse mouth thoroughly with water. • Follow these instructions or use as directed by a dental professional. Use once daily in place of conventional toothpaste unless instructed otherwise by a physician or dentist. ( 2 ) Apply a thin ribbon or pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste using a soft-bristled toothbrush and brush teeth for at least two minutes. ( 2 ) After brushing adults should expectorate. Children 6 to 16 years of age should expectorate and rinse mouth thoroughly with water. ( 2 )

Contraindications

4 CONTRAINDICATIONS Do not use in children under 6 years of age unless recommended by a dentist or physician. Do not use in children under 6 years of age unless recommended by a dentist or physician. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS Allergic reactions and other idiosyncrasies have been rarely reported. Allergic reactions and other idiosyncrasies have been rarely reported. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact 3M ESPE Dental Products Division at 1-800-634-2249 or www.3MESPE.com , or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Frequently Asked Questions

What is Clinpro 5000 used for?

Clinpro 5000 contains sodium fluoride. It is a paste, dentifrice taken oral. Consult your doctor for specific uses.

Is Clinpro 5000 a controlled substance?

Clinpro 5000 is not classified as a controlled substance by the DEA.

What is the generic name for Clinpro 5000?

The generic name for Clinpro 5000 is sodium fluoride. There are 12 other brand versions of sodium fluoride.

What is the NDC code for Clinpro 5000 5 mg/g?

The NDC (National Drug Code) for Clinpro 5000 5 mg/g is 48878-3140, listed by Solventum US LLC.