Sodium monofluorophosphate
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
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
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Postmarketing Experience
There is limited information regarding Postmarketing Experience of Sodium monofluorophosphate in the drug label.
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Drug Interactions
There is limited information regarding Sodium monofluorophosphate Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
- Pregnancy Category
- 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
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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.