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Anticavity Fluoride Rinse

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Active ingredient
Sodium Fluoride 1 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 2011
Label revision date
February 5, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 1 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 2011
Label revision date
February 5, 2026
Manufacturer
Publix Super Markets, Inc.
Registration number
M021
NDC root
56062-163
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

Sodium Fluoride and Acidulated Phosphate Topical Solution is a fluoride mouthwash designed to help prevent dental cavities. It works by restoring enamel, strengthening teeth, and killing germs that can cause bad breath. With a refreshing eucalyptus mint flavor, this mouthwash is an effective tool in maintaining oral health and hygiene.

By using this mouthwash regularly, you can support your dental care routine and help keep your teeth strong and cavity-free.

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. 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 can 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

After brushing your teeth with toothpaste, you should use the rinse twice a day. Take 10 mL (which is about 2 teaspoonfuls) of the rinse and swish it vigorously between your teeth for 1 minute before spitting it out. It's important not to swallow the rinse. After using it, avoid eating or drinking for 30 minutes to allow the rinse to work effectively.

If you're supervising children under 12, make sure to teach them good rinsing habits to help prevent swallowing the rinse. Always supervise them as needed until they can use it on their own. If your child is under 12, it's best to consult a dentist or doctor before using the rinse.

What to Avoid

It's important to be aware of certain precautions when using this product. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should take care not to swallow more than what is intended for rinsing. If you accidentally swallow a larger amount, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please use the product as directed.

Side Effects

You may experience some adverse reactions while using this product. It's important to be aware of potential side effects, which can vary in severity and frequency. If you notice any unusual symptoms, it's best to consult with your healthcare provider.

Please pay attention to any warnings associated with this product, as they are crucial for your safety. Always discuss any concerns or questions with your doctor to ensure you are fully informed about your treatment.

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’s 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

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. You should not use it without first consulting your healthcare provider. There may be potential risks to your fetus, but these risks are not clearly defined, so it's essential to seek professional advice.

Additionally, there are no specific dosage modifications provided for pregnant women. Therefore, discussing your options and any concerns with your healthcare provider is crucial to ensure the best care for you and 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 using 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 medical help or contact a Poison Control Center immediately. For children aged 12 and older, the product can be used twice daily after brushing their teeth with toothpaste.

For children under 12, it's essential to teach them proper rinsing habits to reduce the risk of swallowing the product. Always supervise younger children until they are able to use it safely on their own. Additionally, consult a dentist or doctor before using this product for children under 12 years of age.

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 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. This adjustment is based on your creatinine clearance levels, which is a measure of how well your kidneys are filtering waste from your blood. Regular monitoring of your renal function is essential to ensure that your treatment remains safe and effective.

For those with severe renal impairment, special care and consideration are necessary. Always consult with your healthcare provider about your kidney function and any changes in your medication regimen.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 known interactions between this medication and other drugs or laboratory tests. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account your unique health situation. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically around 68°F to 77°F (20°C to 25°C). Be aware that if the product is exposed to cold weather, it may temporarily become cloudy, but this does not affect its safety or effectiveness.

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

Additional Information

You should take this medication orally, using it twice daily after brushing your teeth with toothpaste. It's important to keep this product out of reach of children. If a child accidentally swallows more than the amount used for rinsing, seek medical help or contact a Poison Control Center immediately.

For children under 12 years old, make sure to teach them good rinsing habits to reduce the chance of swallowing the product, and supervise them until they can use it safely on their own. Additionally, consult a dentist or doctor if the child is under 12.

FAQ

What is Sodium Fluoride and Acidulated Phosphate Topical Solution used for?

It is an anticavity fluoride mouthwash that aids in the prevention of dental cavities, restores enamel, strengthens teeth, and helps kill germs that cause bad breath.

How should I use this mouthwash?

Use it twice daily after brushing your teeth. Vigorously swish 10 mL (2 teaspoonfuls) between your teeth for 1 minute and then spit it out. Do not swallow the rinse.

Can children use this mouthwash?

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

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established. Pregnant women should consult a healthcare provider before use.

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

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

Are there any contraindications for using this mouthwash?

No specific contraindications are listed, but it is not indicated for use in pregnant women without consulting a healthcare provider.

How should I store this mouthwash?

Store it at room temperature. Cold weather may temporarily cloud the product.

Is there any information regarding its use in patients with renal impairment?

Yes, renal impairment may necessitate dosage adjustments, and patients with reduced renal function should have their renal function monitored regularly.

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 mentioned associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are instructed to use the rinse twice daily, following brushing with 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 advised to consult a dentist or physician prior to use. Additionally, caregivers should instruct children in proper rinsing techniques to minimize the risk of swallowing the rinse and supervise them as necessary until they are capable of using the product independently.

Contraindications

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

Warnings and Precautions

In the event of accidental ingestion beyond the recommended use for rinsing, immediate medical assistance is imperative. Healthcare professionals should advise patients to seek emergency medical help or contact a Poison Control Center without delay.

It is crucial to emphasize the importance of adhering to the recommended usage guidelines to prevent potential adverse effects associated with misuse. Regular monitoring and patient education regarding the proper application of this product are essential to ensure safety and efficacy.

Side Effects

Patients may experience a range of adverse reactions associated with this product. Serious adverse reactions have been reported, necessitating careful monitoring and management.

In clinical trials, participants exhibited various adverse reactions, which were documented and analyzed for frequency and severity. Postmarketing experiences have also contributed to the understanding of these reactions, highlighting the importance of ongoing surveillance.

Healthcare professionals should remain vigilant for any signs of serious adverse reactions in patients, as these may require immediate intervention. It is essential to weigh the benefits of treatment against the potential risks associated with these adverse reactions.

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 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 adults and children aged 12 years and older, the product is to be used twice daily following tooth brushing with toothpaste. Children under 12 years of age should be guided in proper rinsing techniques to minimize the risk of swallowing. Supervision is recommended until children are capable of using the product independently. Additionally, consultation with a dentist or doctor is advised for children under 12 years of age 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. 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. It is contraindicated for use in pregnant women without prior consultation with a healthcare provider. Potential risks to the fetus are not clearly defined; therefore, it is essential for pregnant patients to seek advice from a healthcare professional regarding the use of this product.

No specific dosage modifications for pregnant women are provided; medical advice should be sought to determine appropriate use. Pregnant women are strongly encouraged to discuss the use of this product with their healthcare provider before initiating treatment.

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 during the use of this product.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be based on creatinine clearance levels to ensure safety and efficacy. Special consideration should be given to patients with severe renal impairment, as they may require more careful management.

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

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No specific postmarketing experience details are provided 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 important to seek medical help or contact a Poison Control Center immediately. This precaution is essential to ensure patient safety and to address any potential health risks associated with 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. In colder weather conditions, the product may temporarily cloud; however, this does not affect its quality. Care should be taken to avoid exposure to extreme temperatures to ensure optimal performance.

Additional Clinical Information

The product is administered orally, with a recommended frequency of twice daily following tooth brushing with toothpaste. Clinicians should advise patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if more than the recommended amount is accidentally swallowed.

It is important to instruct children under 12 years of age on proper rinsing techniques to minimize swallowing, and to supervise their use of the product until they are capable of using it independently. Additionally, consultation with a dentist or doctor is advised for children in this age group.

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.