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Anticavity Fluoride Rinse

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Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2003
Label revision date
February 13, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Mouthwash
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 2003
Label revision date
February 13, 2026
Manufacturer
Topco Associates LLC
Registration number
M021
NDC root
36800-213
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Fluoride Mouth Rinse is an alcohol-free mouthwash designed to help prevent dental cavities and strengthen your teeth. With a refreshing mint flavor, it not only aids in cavity prevention but also helps freshen your breath. This product is accepted by the American Dental Association (ADA), ensuring its effectiveness in promoting oral health.

Using fluoride (a mineral that helps protect against tooth decay) regularly can be an important part of your dental care routine, contributing to stronger teeth and a healthier smile.

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 helps stop those pesky holes from forming in your teeth. By using it regularly, you can also strengthen your teeth, making them more resilient against decay.

In addition to protecting your teeth, this product freshens your breath, giving you confidence in your smile. With its cavity-fighting properties and breath-freshening benefits, it’s a great addition to your oral care routine.

Dosage and Administration

To use this mouth rinse effectively, start by brushing your teeth with toothpaste. After brushing, remove the cap and pour 10 milliliters (mL) of the rinse, making sure not to fill above the 10 mL mark indicated on the inside of the cap. Next, vigorously swish the rinse between your teeth for one minute, then spit it out. Remember, do not swallow the rinse.

For adults and children aged 6 years and older, you should use this rinse once a day. After rinsing, avoid eating or drinking for 30 minutes to allow the rinse to work effectively. If you are supervising children under 12, make sure to guide them in good rinsing habits to prevent swallowing. For children under 6 years old, it’s best to consult a dentist or doctor before use.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. While there are no listed contraindications, controlled substance classifications, or concerns about abuse or dependence, you should take care when using it.

If you accidentally swallow more than what is intended for rinsing, please seek professional assistance or contact a Poison Control Center immediately. Your safety is a priority, so always use the product as directed.

Side Effects

You should be aware that this product is not manufactured or distributed by Chattem, Inc., the company behind Act® Anticavity Fluoride Mouthwash. While specific adverse reactions and warnings related to this product are not detailed here, it's important to consult the product packaging or a healthcare professional for comprehensive information regarding any potential side effects or concerns. Always prioritize your health and safety by staying informed.

Warnings and Precautions

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

While there are no specific laboratory tests or emergency medical help instructions provided, it's always a good idea to stay vigilant. If you experience any unusual symptoms or reactions, stop using the product and call your doctor for guidance. Your health and safety are paramount, 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’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency services 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, which means that it may not be safe for you or your developing baby. In fact, using this product while pregnant is not recommended due to potential risks to the fetus.

If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using this product. They can provide guidance and help you understand any potential risks involved. Your health and the health of your baby are the top priority, so always seek professional advice when considering any medication or treatment during pregnancy.

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 it may pose 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 your child accidentally swallows more than what is needed for rinsing, seek professional help or contact a Poison Control Center right away. For children aged 6 years and older, you can use this product once a day after brushing their teeth.

For children under 12, make sure to teach them proper rinsing habits to help prevent swallowing. Always supervise younger children until they can use the product safely on their own. If your child is under 6 years old, it's best to consult with 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, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 kidney function) is reduced, your healthcare provider will closely monitor your condition. Regular renal function tests are essential to ensure your kidneys are working properly.

For those with moderate to severe renal impairment, a lower dose of medication is typically recommended. Additionally, if you have end-stage renal disease, special considerations will be necessary regarding your treatment. 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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is Fluoride Mouth Rinse?

Fluoride Mouth Rinse is an alcohol-free, anticavity mouthwash with a mint flavor that helps prevent dental cavities and strengthen teeth.

How should I use Fluoride Mouth Rinse?

Use Fluoride Mouth Rinse once a day after brushing your teeth. Pour 10 milliliters into the cap, swish it between your teeth for 1 minute, and then spit it out.

What should I do if I accidentally swallow Fluoride Mouth Rinse?

If more than the recommended amount is swallowed, seek professional assistance or contact a Poison Control Center immediately.

Is Fluoride Mouth Rinse safe for children?

Children under 6 years of age should consult a dentist or doctor before use. For children under 12, supervise them to ensure they do not swallow the rinse.

Can I use Fluoride Mouth Rinse during pregnancy?

The safety of Fluoride Mouth Rinse during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus. Consult a healthcare provider before use.

Are there any warnings associated with Fluoride Mouth Rinse?

Keep Fluoride Mouth Rinse out of reach of children, and if swallowed in excess, seek medical help. Always read the directions for proper use.

What are the benefits of using Fluoride Mouth Rinse?

Fluoride Mouth Rinse aids in the prevention of dental cavities, helps strengthen teeth, and freshens breath.

How should Fluoride Mouth Rinse be stored?

Store Fluoride Mouth Rinse at room temperature.

Is there any information on drug interactions with Fluoride Mouth Rinse?

No specific drug interactions information is provided for Fluoride Mouth Rinse.

What should I do if I have kidney problems and want to use Fluoride Mouth Rinse?

Patients with renal impairment may need dosage adjustments and should be closely monitored. Consult your healthcare provider for guidance.

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 strengthening teeth and helps to prevent the formation of cavities. Additionally, it contributes to freshening breath.

Dosage and Administration

Adults and children aged 6 years and older should use the rinse once daily, following brushing with toothpaste.

To administer, the cap should be removed, and 10 milliliters (mL) of the rinse should be poured, ensuring that the liquid does not exceed the 10 mL mark indicated on the inside of the cap. The patient should then vigorously swish the 10 mL of rinse between their teeth for a duration of 1 minute before spitting it out. It is imperative that the rinse is not swallowed.

After rinsing, patients should refrain from eating or drinking for 30 minutes to maximize the effectiveness of the treatment.

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 of this product is contraindicated in situations where accidental ingestion beyond the recommended rinsing amount occurs. In such cases, immediate professional assistance or contact with a Poison Control Center is advised. No other contraindications have been identified.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions when using this product.

In the event that more than the recommended amount intended for rinsing is accidentally ingested, it is crucial to seek professional medical assistance or contact a Poison Control Center immediately. This precaution is essential to ensure the safety and well-being of the patient.

Healthcare professionals should remain vigilant and monitor patients for any adverse reactions or complications associated with the use of this product. While specific laboratory tests have not been provided, it is advisable to maintain a general awareness of the patient's overall health status and any relevant medical history that may influence the safe use of this product.

In case of any concerning symptoms or reactions, healthcare providers should instruct patients to discontinue use and consult their physician for further evaluation and guidance.

Side Effects

This product is not manufactured or distributed by Chattem, Inc., distributor of Act® Anticavity Fluoride Mouthwash. There are no specific adverse reactions listed for this product. However, it is important to note that patients should be aware of potential warnings associated with its use. Users are advised to consult the product labeling for any specific warnings or contraindications that may apply.

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, professional assistance should be sought or a Poison Control Center contacted immediately.

For children aged 6 years and older, the product is to be used once daily after brushing teeth with toothpaste. It is important to instruct children under 12 years of age in proper rinsing habits to minimize the risk of swallowing. Supervision is recommended for 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 advised prior to use.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Use of this product is contraindicated in pregnancy due to potential risk to the fetus. Pregnant women should consult a healthcare provider before using this product to discuss potential risks and benefits.

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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. For those with reduced creatinine clearance, close monitoring is essential to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. A reduced dose is recommended for patients with moderate to severe renal impairment. Additionally, special considerations should be taken into account for patients with end-stage renal disease to optimize treatment outcomes.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified adverse reactions associated with the use of this product. It is important to note that this product is not manufactured or distributed by Chattem, Inc., the distributor of Act® Anticavity Fluoride Mouthwash. Reports of adverse reactions have been received voluntarily and through surveillance programs, contributing to the ongoing assessment of the product's safety profile.

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 professional assistance 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

No further data are available.

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.

Learn more in our Editorial Policy

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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.