Sodium fluoride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [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 fluoride is a dental agent that is FDA approved for the prophylaxis of dental caries. Common adverse reactions include dental fluorosis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Aids in the prevention of dental cavities
Dosage
- Use once a day after brushing your teeth with a toothpaste
- Hold bottle upright and squeeze. Fill to FILL LINE pour out. Only the correct 10 milliliters dose will pour out.
- Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sodium fluoride in adult patients.
Non–Guideline-Supported Use
Indications
- Sensitive dentin
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
- Aids in the prevention of dental cavities
Dosing
Children 6 years of age and older
- Use once a day after brushing your teeth with a toothpaste
- Hold bottle upright and squeeze. Fill to FILL LINE pour out. Only the correct 10 milliliters dose will pour out.
Children under 6 years of age: consult a dentist or doctor
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sodium flouride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium fluoride in pediatric patients.
Contraindications
There is limited information regarding Sodium fluoride Contraindications in the drug label.
Warnings
Keep out of reach of children.
If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Sodium fluoride in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Sodium fluoride in the drug label.
Drug Interactions
There is limited information regarding Sodium fluoride Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Sodium fluoride in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sodium fluoride in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Sodium fluoride during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Sodium fluoride with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Sodium fluoride with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Sodium fluoride with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Sodium fluoride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Sodium fluoride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Sodium fluoride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Sodium fluoride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sodium fluoride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Sodium fluoride in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
Monitoring
There is limited information regarding Monitoring of Sodium fluoride in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Sodium fluoride in the drug label.
Overdosage
There is limited information regarding Sodium fluoride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
Mechanism of Action
There is limited information regarding Sodium fluoride Mechanism of Action in the drug label.
Structure
There is limited information regarding Sodium fluoride Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Sodium fluoride in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Sodium fluoride in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Sodium fluoride in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Sodium fluoride in the drug label.
How Supplied
There is limited information regarding Sodium fluoride How Supplied in the drug label.
Storage
There is limited information regarding Sodium fluoride Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Sodium fluoride in the drug label.
Precautions with Alcohol
- Alcohol-Sodium fluoride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
ACT ANTICAVITY FLUORIDE CINNAMON
Look-Alike Drug Names
There is limited information regarding Sodium fluoride 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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