Sodium monofluorophosphate

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Sodium monofluorophosphate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Sodium monofluorophosphate is a OTC dental preaparation that is FDA approved for the treatment of cavities. Common adverse reactions include flatulence and abdominal bloating.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • helps protect against cavities

Directions

Sodium monoflurophosphate Directions.png

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium monofluorophosphate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium monofluorophosphate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Sodium monofluorophosphate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium monofluorophosphate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium monofluorophosphate in pediatric patients.

Contraindications

There is limited information regarding Sodium monofluorophosphate Contraindications in the drug label.

Warnings

  • Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

flatulence and abdominal bloating

<--Postmarketing Experience-->

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Sodium monofluorophosphate in the drug label.

<--Drug Interactions-->

Drug Interactions

There is limited information regarding Sodium monofluorophosphate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sodium monofluorophosphate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sodium monofluorophosphate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sodium monofluorophosphate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Sodium monofluorophosphate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Sodium monofluorophosphate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Sodium monofluorophosphate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sodium monofluorophosphate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sodium monofluorophosphate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sodium monofluorophosphate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sodium monofluorophosphate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sodium monofluorophosphate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of Sodium monofluorophosphate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Sodium monofluorophosphate in the drug label.

Overdosage

  • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Pharmacology

This image is provided by Wikipedia

Mechanism of Action

There is limited information regarding Sodium monofluorophosphate Mechanism of Action in the drug label.

Structure

ACTIVE INGREDIENT
  • Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

INACTIVE INGREDIENTS

  • dicalcium phosphate dihydrate, water, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Sodium monofluorophosphate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Sodium monofluorophosphate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Sodium monofluorophosphate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Sodium monofluorophosphate in the drug label.

How Supplied

There is limited information regarding Sodium monofluorophosphate How Supplied in the drug label.

Storage

There is limited information regarding Sodium monofluorophosphate Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Sodium monofluorophosphate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 85 GRAM TUBE

Colgate® Fluoride Toothpaste

ADA Accepted American Dental Association®

NET WT 3.0 OZ (85 g)

Cavity Protection

Strengthens Teeth with Active Fluoride

Great Regular Flavor

This image is provided by the National Library of Medicine.

PRINCIPAL DISPLAY PANEL - 85 GRAM TUBE CARTON

Colgate® Fluoride Toothpaste

ADA Accepted American Dental Association®

NET WT 3.0 OZ (85 g)

Cavity Protection

Strengthens Teeth with Active Fluoride

Great Regular Flavor

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

{{#ask: Label Page::Sodium monofluorophosphate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

QUESTIONS OR COMMENTS?

  • Call toll-free 1-800-468-6502

Precautions with Alcohol

  • Alcohol-Sodium monofluorophosphate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • COLGATE TOOTHPASTE GREAT REGULAR FLAVOR®[1]

Look-Alike Drug Names

There is limited information regarding Sodium monofluorophosphate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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