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Closys

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Active ingredient
Sodium Fluoride 0.05 g/100 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
December 23, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.05 g/100 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
December 23, 2025
Manufacturer
Rowpar Pharmaceuticals, Inc.
Registration number
M021
NDC root
58578-1234
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to help prevent dental cavities, which are small holes in your teeth caused by decay. By using this product, you can support your oral health and reduce the risk of developing cavities over time. It comes in various packaging sizes, including a 473 mL carton, making it easy to incorporate into your daily dental care routine.

Uses

You can use this product to help prevent dental cavities. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of tooth decay. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

After you brush your teeth with toothpaste, you can use this mouth rinse once a day. Start by removing the cap and pouring out 10 ml (which is about 2 teaspoons) of the rinse. Vigorously swish it between your teeth for 1 minute, then spit it out. Remember, do not swallow the rinse. After using it, avoid eating or drinking for 30 minutes to allow the rinse to work effectively.

If you're helping children under 12, make sure to teach them how to rinse properly to prevent swallowing the rinse. It's important to supervise them until they can use 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 should be aware that there are no specific adverse reactions listed for this medication. However, it’s important to stay informed about any potential side effects that may arise. If you experience any unusual symptoms or reactions while taking this medication, please consult your healthcare provider for guidance.

Warnings and Precautions

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is used for rinsing, you should seek medical help immediately or contact a Poison Control Center.

In case of accidental ingestion, getting emergency medical assistance is crucial. Always act quickly to ensure safety.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

Pregnancy Use

When it comes to using ClōSYS® Silver® Anticavity Fluoride Rinse during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the manufacturer has not provided guidance on how this product may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any new products, including oral rinses. They can help you make informed decisions based on your individual health needs and circumstances.

Lactation Use

If you are breastfeeding, you can use ClōSYS® Silver® Anticavity Fluoride Rinse without any specific warnings or recommendations against it. Currently, there is no information available about whether this product is passed into breast milk or if it poses any risk to your nursing infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When using this product for children, it's important to follow specific guidelines to ensure their safety and effectiveness. For children aged 6 years and older, you can use it once a day after brushing their teeth. However, if your child is under 12, make sure to teach them proper rinsing habits to help prevent swallowing the product. It's also a good idea to supervise younger children until they can use it independently.

For children under 6 years old, it's best to consult with a dentist or doctor before use. This ensures that you are making the right choice for their dental care. Always prioritize their safety and comfort when introducing new dental products.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you have concerns about how this medication might affect you or an older adult in your care, please consult with a healthcare professional for personalized advice.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This adjustment is based on your creatinine clearance levels, which is a measure of how well your kidneys are filtering waste from your blood. To ensure your safety, your healthcare provider will monitor your renal function regularly, both before starting any new treatment and at intervals during your therapy.

Make sure to discuss any concerns with your doctor, as they will perform necessary renal function tests to guide your treatment plan effectively. Regular monitoring helps to ensure that your medication is safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Your healthcare provider will likely monitor your liver function tests (which are blood tests that check how well your liver is working) to keep an eye on your liver health while you are taking the medication. Special precautions will be taken when administering the drug to ensure your safety, so be sure to discuss any concerns with your doctor.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure your product or device remains safe and effective, always check that the safety seal is intact before use. If the seal is broken or missing, do not use the product, as this could compromise its safety and effectiveness.

For proper storage, keep the product in a cool, dry place, away from direct sunlight and extreme temperatures. This will help maintain its quality and ensure it functions as intended. Always handle the product with care to avoid any damage.

Additional Information

No further information is available.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of dental cavities.

What is the recommended dosage for adults and children 6 years and older?

Use once a day after brushing your teeth. Swish 10 ml (2 tsp) of rinse between your teeth for 1 minute and then spit it out.

What should I do if I accidentally swallow more than the recommended amount?

Get medical help or contact a Poison Control Center right away.

Can children under 6 years use this rinse?

Consult a dentist or doctor before use for children under 6 years of age.

Are there any contraindications for this drug?

No specific contraindications are listed.

Is there any information regarding use during pregnancy?

No specific information regarding safety concerns or dosage modifications during pregnancy is provided.

What precautions should I take if I have renal impairment?

Renal function should be monitored regularly, and dosage adjustments may be necessary based on creatinine clearance levels.

What should I know about using this drug if I have hepatic impairment?

Monitor liver function tests, as dosage adjustments may be necessary for patients with hepatic impairment.

What should I do if the safety seal is broken or missing?

Do not use the product if the safety seal is broken or missing.

Are there any specific warnings or adverse reactions associated with this drug?

No specific warnings or adverse reactions are listed.

Packaging Info

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

Packaging configurations for Closys.
Details

Drug Information (PDF)

This file contains official product information for Closys, 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 is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse once daily, following the brushing of teeth with toothpaste. The cap should be removed, and 10 ml (2 teaspoons) of the rinse should be poured out. The user must vigorously swish the rinse between the teeth for 1 minute before spitting it out. It is imperative that the rinse is not swallowed. Additionally, individuals should refrain from eating or drinking for 30 minutes after rinsing to ensure optimal effectiveness.

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 using the product without assistance.

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

Contraindications

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

Warnings and Precautions

It is imperative to keep this product out of the reach of children. In the event that more than the recommended amount for rinsing is accidentally ingested, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

No specific laboratory tests are recommended for monitoring in relation to the use of this product. However, vigilance in patient education regarding the proper use and potential risks associated with accidental ingestion is essential to ensure safety.

Side Effects

WARNING:

In clinical trials and postmarketing experiences, no specific adverse reactions have been identified. However, healthcare professionals should remain vigilant and monitor patients for any unexpected effects during treatment.

Drug Interactions

There are currently no documented drug interactions associated with 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 Closys (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Closys.
Details

Pediatric Use

Pediatric patients aged 6 years and older are advised to use the product once daily after brushing their teeth with toothpaste. For children under 12 years of age, it is important to instruct them in proper rinsing habits to minimize the risk of swallowing. Supervision is recommended for these children until they are 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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of ClōSYS® Silver® Anticavity Fluoride Rinse during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant women, as the potential effects on fetal outcomes are not established. It is advisable to weigh the benefits against any unknown risks when recommending this rinse to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of ClōSYS® Silver® Anticavity Fluoride Rinse in 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 creatinine clearance levels. It is important to perform renal function tests prior to initiating therapy and to monitor renal function regularly throughout treatment. Regular monitoring ensures that any necessary dosage adjustments can be made to accommodate changes in renal function.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in this population to assess the degree of impairment and guide treatment decisions. Special precautions should be taken when administering the drug to patients with liver problems, as their compromised liver function may increase the risk of adverse effects or alter the pharmacokinetics of the medication.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

  1. Assessment and Monitoring: Conduct a thorough evaluation of the patient's vital signs and mental status. Continuous monitoring may be necessary to detect any changes in the patient's condition.

  2. Supportive Care: Initiate supportive measures as needed, which may include airway management, oxygen supplementation, intravenous fluids, and other interventions to stabilize the patient.

  3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies tailored to the substance involved in the overdose.

  4. Symptomatic Treatment: Address any specific symptoms that arise, such as seizures, arrhythmias, or severe agitation, with appropriate pharmacological interventions.

  5. Documentation and Reporting: Ensure that all findings, interventions, and patient responses are meticulously documented. Reporting the incident to relevant health authorities may also be warranted, depending on the substance and circumstances of the overdose.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to implement a comprehensive management plan that prioritizes patient safety and effective symptom management in cases of suspected overdose.

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 to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for rinsing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This information is crucial for ensuring patient safety and preventing potential adverse effects associated with misuse.

Storage and Handling

The product is supplied in packaging that includes a safety seal. It is imperative that the product not be used if the safety seal is broken or missing, as this may compromise the integrity and safety of the product.

For optimal storage, the product should be kept in a controlled environment, away from extreme temperatures and humidity. Specific temperature ranges and container requirements are not provided; however, general best practices for pharmaceutical storage should be followed to ensure product stability and efficacy. Special handling needs are not specified, but care should be taken to maintain the product's integrity throughout its storage and handling processes.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Closys, 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 Closys, 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.

Learn more in our Editorial Policy

Last AI update:

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.