Stannous fluoride
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Overview
Stannous fluoride is an anticavity, antigingivitis, antihypersensitivity mouthrinse that is FDA approved for the prophylaxis of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. Common adverse reactions include surface staining of the teeth.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Adults and children 6 years of age and older:
- Do not use before mixing with water. Use immediately after preparing the rinse.
- Remove cap and replace with pump.
- Rotate spout container clockwise to extend.
- Depress pump until rinse comes to the tip of the pump.
- Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.
- Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
- Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Stannous fluoride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Stannous fluoride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Adults and children 6 years of age and older:
- Do not use before mixing with water. Use immediately after preparing the rinse.
- Remove cap and replace with pump.
- Rotate spout container clockwise to extend.
- Depress pump until rinse comes to the tip of the pump.
- Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.
- Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
- Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
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 Stannous fluoride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Stannous fluoride in pediatric patients.
Contraindications
There is limited information regarding Stannous fluoride Contraindications in the drug label.
Warnings
- Keep out of reach of children.
- Do not swallow. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison *Control Center right away.
- Do not use until diluted.
- This product may produce surface staining of the teeth.
- Adequate tooth-brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Stannous fluoride Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Stannous fluoride Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Stannous fluoride Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Stannous fluoride in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Stannous fluoride in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Stannous fluoride during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Stannous fluoride in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Stannous fluoride in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Stannous fluoride in geriatric settings.
Gender
There is no FDA guidance on the use of Stannous fluoride with respect to specific gender populations.
Race
There is no FDA guidance on the use of Stannous fluoride with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Stannous fluoride in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Stannous fluoride in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Stannous fluoride in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Stannous fluoride in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Stannous fluoride Administration in the drug label.
Monitoring
There is limited information regarding Stannous fluoride Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Stannous fluoride and IV administrations.
Overdosage
There is limited information regarding Stannous 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 Stannous fluoride Mechanism of Action in the drug label.
Structure
There is limited information regarding Stannous fluoride Structure in the drug label.
Pharmacodynamics
There is limited information regarding Stannous fluoride Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Stannous fluoride Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Stannous fluoride Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Stannous fluoride Clinical Studies in the drug label.
How Supplied
There is limited information regarding Stannous fluoride How Supplied in the drug label.
Storage
- Store at controlled room temperature 59° - 86°F (15°-30°C). Protect from freezing.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Stannous fluoride Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Stannous fluoride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Stannous fluoride Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Stannous 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.