ADD CONDITION

items per page

Fluoride Mouth Rinse Anticavity

Last content change checked dailysee data sync status

Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2010
Label revision date
February 18, 2026
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
Marketed in the U.S.
Since 2010
Label revision date
February 18, 2026
Manufacturer
Target Corporation
Registration number
M021
NDC root
11673-213

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 product is a mouthrinse that aids in the prevention of dental cavities and helps strengthen your teeth. It contains anticavity fluoride, which works to protect your teeth from decay, and it also freshens your breath with a pleasant mint flavor. Accepted by the American Dental Association (ADA), this mouthrinse is designed to be a helpful addition to your oral hygiene routine.

In addition to its cavity-fighting properties, this mouthrinse is safety sealed for your protection, ensuring that you receive a product that is both effective and trustworthy. With regular use, it can contribute to better dental health and a brighter smile.

Uses

You can use this product to help keep your teeth healthy and strong. It aids in the prevention of dental cavities, which are small holes that can form in your teeth due to decay. By using this product regularly, you can help prevent cavities and strengthen your teeth, making them more resilient against damage. Taking care of your dental health is important, and this product can be a helpful part of your routine.

Dosage and Administration

To use this mouth rinse effectively, you should do so once a day after brushing your teeth with toothpaste. Start by removing the cap and pouring 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 10 mL of rinse between your teeth for one minute, then spit it out. It's important that you do not swallow the rinse. After using the mouth rinse, avoid eating or drinking for 30 minutes to allow it to work effectively. If you're supervising children under 12, make sure to teach them good rinsing habits to minimize the chance of 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 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, please seek professional help or contact a Poison Control Center right away. Your safety is a priority, so always use the product as directed.

Side Effects

You can feel reassured that there are no specific adverse reactions or warnings associated with this medication. This means that, based on current information, it is generally considered safe for use without notable side effects. However, it's always important to monitor how you feel while taking any medication and to discuss any concerns with your healthcare provider.

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.

To ensure your safety, always follow the recommended usage instructions carefully. If you experience any unusual symptoms or reactions, stop using the product and call your doctor for further 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 always important to be aware of the signs of an overdose, which can include unusual symptoms or worsening of your condition. If you suspect that you or someone else may have taken too much of the medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your healthcare provider or local emergency services right away. They can provide guidance on what steps to take next. Always remember to keep medications out of reach of children and to follow the prescribed dosage to prevent any potential risks.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of sodium fluoride mouthwash during pregnancy has not been established. In fact, using this mouthwash is not recommended because it may pose potential risks to your developing baby. Fluoride exposure during pregnancy could carry certain risks, so it's essential to consult your healthcare provider for personalized advice.

Before using any fluoride products, including mouthwash, you should discuss it with your healthcare provider. They can help you understand the benefits and potential risks, and guide you on the appropriate use and dosage if necessary. Your health and the health of your baby are the top priority, so make sure to seek professional guidance.

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 used for rinsing, seek professional help or contact a Poison Control Center right away. For children aged 6 years and older, it can be used once a day after brushing their teeth with toothpaste.

If your child is under 12, make sure to teach them good rinsing habits to help minimize swallowing. Always supervise younger children until they are able to use the product safely on their own. For children 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 before starting the medication. 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. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, you may require a lower dose of your medication. Additionally, if you have significant renal dysfunction, special monitoring is recommended to manage your health effectively. Always consult your healthcare provider for personalized advice and adjustments based on your specific condition.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 the best performance and safety of your product, it is important to store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Always follow any specific instructions provided with the product for safe use and disposal.

Additional Information

You should take this medication orally, once a day, after brushing your teeth with toothpaste if you are an adult or a child aged 6 years and older. If you are supervising a child under 12, make sure to teach them good rinsing habits to help prevent swallowing the medication. For children under 6 years old, it's important to consult a dentist or doctor before use.

FAQ

What is the purpose of this mouthrinse?

This mouthrinse aids in the prevention of dental cavities, helps strengthen teeth, and freshens breath.

How should I use this mouthrinse?

Use 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. Do not swallow the rinse.

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

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Is this mouthrinse safe for children?

Children under 12 years should be instructed in good rinsing habits and supervised until capable of using it without supervision. Consult a dentist or doctor for children under 6 years.

Can pregnant women use this mouthrinse?

The safety of this product during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus. Consult a healthcare provider for advice.

What precautions should nursing mothers take?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

How should I store this mouthrinse?

Store the mouthrinse at room temperature.

Are there any known side effects?

No specific adverse reactions or warnings are listed for this mouthrinse.

What should I do if I have renal impairment?

Patients with renal impairment may require dosage adjustments and should have their renal function monitored regularly.

Packaging Info

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

Packaging configurations for Fluoride Mouth Rinse Anticavity.
Details

Drug Information (PDF)

This file contains official product information for Fluoride Mouth Rinse Anticavity, 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.

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 not to exceed the 10 mL mark indicated on the inside of the cap. The patient should 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 allow optimal efficacy of the product. 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 physician is recommended prior to use.

Contraindications

Use of this product is contraindicated in the event of accidental ingestion beyond the recommended rinsing amount. In such cases, it is imperative to seek professional assistance or contact a Poison Control Center immediately. No other contraindications have been identified.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Warnings This product is intended for use as directed. Any misuse or overuse may lead to adverse effects.

General Precautions In the event that more than the recommended amount used for rinsing is accidentally ingested, it is imperative to seek professional medical assistance or contact a Poison Control Center immediately. Prompt action is essential to ensure patient safety and mitigate potential risks associated with ingestion.

Side Effects

No specific adverse reactions or warnings have been identified in clinical trials or postmarketing experiences. As such, there are no documented adverse reactions associated with the use of this product. Patients and healthcare providers should remain vigilant and report any unexpected effects or concerns 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 Fluoride Mouth Rinse Anticavity (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fluoride Mouth Rinse Anticavity.
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 or contact with a Poison Control Center should be sought 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 may be necessary for younger 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

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. The use of sodium fluoride mouthwash is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with fluoride exposure during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for personalized advice.

Pregnant women should seek guidance from a healthcare professional regarding the use and dosage of this product. It is recommended that pregnant individuals discuss the use of fluoride products with their healthcare provider to weigh the benefits against potential risks.

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. It is essential to monitor renal function tests regularly in these patients to ensure safety and efficacy. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose may be required. Additionally, special monitoring is advised for patients with significant renal dysfunction to mitigate potential risks associated with treatment.

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

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 of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, including airway management, oxygen supplementation, and intravenous fluids.

If the specific agent involved in the overdose is known, appropriate antidotes or specific treatments should be administered as indicated. Continuous monitoring of the patient’s condition is crucial, and healthcare providers should be prepared to manage complications that may arise during the course of treatment.

In all cases of suspected overdose, it is advisable to contact a poison control center or consult relevant clinical guidelines for further management recommendations.

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

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 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 efficacy and integrity. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

Patients aged 6 years and older are advised to administer the medication orally once a day, following brushing with toothpaste. Clinicians should instruct children under 12 years in proper rinsing techniques to minimize swallowing and supervise their use until they can do so independently. For children under 6 years, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

This file contains official product information for Fluoride Mouth Rinse Anticavity, 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 Fluoride Mouth Rinse Anticavity, 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.