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Anticavity Fluoride Rinse

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Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2006
Label revision date
March 12, 2026
Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2006
Label revision date
March 12, 2026
Manufacturer
Nice-Pak Products, LLC
Registration number
M021
NDC root
11344-163

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Drug Overview

Swan® is an anticavity fluoride rinse designed to help you maintain good oral health. It contains sodium fluoride and acidulated phosphate, which work together to aid in the prevention of dental cavities, restore enamel, and strengthen your teeth. Additionally, this rinse freshens your breath and helps kill the germs that cause bad breath, making it a beneficial addition to your daily oral care routine.

With a refreshing eucalyptus mint flavor, Swan® is comparable to other popular mouthwashes, providing a comprehensive approach to dental hygiene. By incorporating this rinse into your routine, you can take proactive steps to protect your teeth and keep your smile healthy.

Uses

You can use this product to help keep your teeth healthy and strong. It aids in the prevention of dental cavities, which means it can help stop those pesky holes from forming in your teeth. Additionally, it works to restore enamel, the protective outer layer of your teeth, and strengthens them overall.

Not only does this product help prevent cavities, but it also helps kill the germs that cause bad breath, leaving your mouth feeling fresh. By incorporating this into your dental care routine, you can take important steps toward maintaining your oral health.

Dosage and Administration

To use this mouth rinse effectively, you should follow a simple routine. For adults and children aged 6 years and older, use the rinse twice a day after brushing your teeth. Measure out 10 mL (which is about 2 teaspoonfuls) of the rinse and swish it vigorously between your teeth for one minute before spitting it out. Remember, it’s important not to swallow the rinse.

After using the mouth rinse, avoid eating or drinking for 30 minutes to allow it to work effectively. If you’re helping a child under 12, make sure to teach them how to rinse properly to prevent swallowing the rinse, and supervise them until they can do it on their own. For children under 6 years old, it’s best to consult a dentist or doctor before using the rinse.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. While there are no listed contraindications or concerns about abuse, misuse, or dependence, you should take care when using it. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please follow these guidelines closely.

Side Effects

You may experience some adverse reactions while using this product. It's important to be aware of these potential side effects, as they can vary in severity and frequency.

If you notice any unusual symptoms or reactions, please consult your healthcare provider for guidance. Your safety and well-being are paramount, so don't hesitate to reach out if you have any concerns.

Warnings and Precautions

It's important to be aware of some key warnings when using this product. If you accidentally swallow more than what is intended for rinsing, seek emergency medical help immediately or contact a Poison Control Center.

Additionally, always follow the recommended usage instructions to avoid any potential risks. If you experience any unusual symptoms or reactions while using this product, stop use and call your doctor for further guidance. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

The safety of this product during pregnancy has not been established, so it's important to approach its use with caution. Fluoride, which is present in this product, can pose risks to the developing fetus if ingested in excessive amounts. Therefore, if you are pregnant or planning to become pregnant, it is crucial to consult your healthcare provider before using this product. They can provide personalized advice and help you make informed decisions regarding your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is needed for rinsing, seek medical help or contact a Poison Control Center immediately. For children aged 6 years and older, you can help them use the rinse twice daily after brushing their teeth. They should swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for one minute and then spit it out. Make sure they do not swallow the rinse and avoid eating or drinking for 30 minutes afterward.

For children under 12, it's essential to teach them proper rinsing habits to reduce the chance of swallowing the rinse. Always supervise younger children until they can use the product safely on their own. If your child is under 6 years old, consult a dentist or doctor before use.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. If your creatinine clearance (a measure of how well your kidneys are filtering waste) is reduced, your healthcare provider will closely monitor your condition. Regular renal function tests will be necessary to keep track of how well your kidneys are working.

For those with significant renal impairment, a lower dose of medication is typically recommended. Additionally, if you have end-stage renal disease, special considerations will be necessary to ensure your treatment is safe and effective. Always discuss your kidney health with your doctor to ensure you receive the best care.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20°C and 25°C (68°F and 77°F). This temperature range helps maintain its effectiveness. Be aware that if the product is exposed to cold weather, it may temporarily appear cloudy, but this does not affect its quality or safety.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, please follow them carefully to ensure safe and responsible disposal.

Additional Information

You should take this medication orally, twice a day, after brushing your teeth with toothpaste. If you have children under 12, it's important to teach them good rinsing habits to help prevent swallowing the medication. Make sure to supervise younger children until they can use it safely on their own. If your child is under 6 years old, consult a dentist or doctor for guidance.

FAQ

What is Swan®?

Swan® is an ANTICAVITY fluoride rinse that aids in the prevention of dental cavities and helps restore enamel.

How should I use Swan®?

Use Swan® twice daily after brushing your teeth. Vigorously swish 10 mL (2 teaspoonfuls) of the rinse between your teeth for 1 minute and then spit it out.

Can children use Swan®?

Yes, children 6 years of age and older can use Swan®, but those under 12 should be instructed in good rinsing habits and supervised as necessary.

What should I do if I accidentally swallow Swan®?

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

Is Swan® safe to use during pregnancy?

The safety of Swan® during pregnancy has not been established, so consult a healthcare provider before use if pregnant or planning to become pregnant.

What are the key benefits of using Swan®?

Swan® helps prevent cavities, restores enamel, strengthens teeth, freshens breath, and kills germs that cause bad breath.

What flavor does Swan® have?

Swan® has an eucalyptus mint flavor.

How should Swan® be stored?

Store Swan® at a controlled room temperature of 20⁰ - 25⁰C (68⁰ - 77⁰F).

Are there any contraindications for using Swan®?

No specific contraindications are listed, but caution is advised as fluoride can pose risks if ingested in excessive amounts.

What should I do if I have renal impairment?

Patients with renal impairment may need dosage adjustments and should be closely monitored for kidney function.

Packaging Info

Below are the non-prescription pack sizes of Anticavity Fluoride Rinse (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Anticavity Fluoride Rinse.
Details

Drug Information (PDF)

This file contains official product information for Anticavity Fluoride Rinse, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It aids in cavity prevention by restoring enamel and strengthening teeth. Additionally, it helps eliminate germs that contribute to bad breath.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 mL (2 teaspoonfuls) of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed.

Patients should refrain from eating or drinking for 30 minutes following the rinsing procedure to ensure optimal efficacy. For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child is capable of performing the rinsing procedure independently.

For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

Use is contraindicated if more than the recommended amount for rinsing is accidentally swallowed. In such cases, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

In the event of accidental ingestion beyond the recommended use for rinsing, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center or seek emergency medical help without delay.

It is imperative to adhere strictly to the recommended usage guidelines to mitigate the risk of adverse effects associated with this product. Regular monitoring and assessment of the patient's condition are essential to ensure safe and effective use.

Side Effects

Patients receiving this product may experience a range of adverse reactions. Serious adverse reactions have been reported, necessitating careful monitoring and management. Common adverse reactions include those that may not require immediate medical attention but should be communicated to healthcare providers.

In clinical trials, participants exhibited various adverse reactions, which were documented to assess the safety profile of the product. Postmarketing experiences have also contributed to the understanding of these reactions, highlighting the importance of ongoing surveillance and reporting.

Healthcare professionals are advised to remain vigilant for any signs of serious adverse reactions and to provide appropriate interventions as necessary. It is essential for patients to report any unexpected or severe symptoms to their healthcare provider promptly.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Anticavity Fluoride Rinse (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Anticavity Fluoride Rinse.
Details

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, the recommended usage is twice daily after brushing teeth with toothpaste. They should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute and then spit it out. It is important that they do not swallow the rinse and refrain from eating or drinking for 30 minutes following the rinse.

Children under 12 years of age should be instructed in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be necessary until the child is capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Caution is advised, as fluoride can pose risks to the fetus if ingested in excessive amounts. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. No specific dosage modifications for pregnant individuals are provided.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to closely monitor patients with reduced creatinine clearance to ensure safe and effective use of the medication. Regular renal function tests should be performed to assess kidney function and guide treatment decisions.

For patients with significant renal impairment, a reduced dose is recommended to minimize the risk of adverse effects. Additionally, special considerations should be taken into account for patients with end-stage renal disease, as their treatment may require further modifications to dosing and monitoring protocols.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse effects that may arise. In the event of suspected overdosage, it is recommended to initiate supportive care and symptomatic treatment as necessary.

Healthcare providers should consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the individual case. Continuous assessment of the patient's clinical status is essential to ensure appropriate interventions are implemented promptly.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients that if more than the recommended amount used for rinsing is accidentally swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately. This information is essential for ensuring patient safety and prompt action in case of accidental ingestion.

Storage and Handling

The product is supplied in configurations that are compliant with the National Drug Code (NDC) standards. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F).

It is important to note that exposure to cold weather may cause temporary cloudiness in the product. Care should be taken to avoid such conditions to maintain product integrity.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of twice daily following tooth brushing. Clinicians should instruct patients, particularly children under 12 years of age, on proper rinsing techniques to minimize swallowing, and supervision is advised until the child can use the product independently. For children under 6 years, consultation with a dentist or doctor is recommended.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Anticavity Fluoride Rinse, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Anticavity Fluoride Rinse, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.