Sodium monofluorophosphate

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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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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
There is limited information regarding Postmarketing Experience of Sodium monofluorophosphate in the drug label.

# 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

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

## Structure
- 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

## 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

### 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

### Ingredients and Appearance

# 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

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

# Drug Shortage Status

# Price