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Anticavity

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Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
February 6, 2026
Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
February 6, 2026
Manufacturer
Retail Business Services, LLC 
Registration number
M021
NDC root
72476-971

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Drug Overview

CAREONE® is an anti-cavity mouthwash that helps strengthen your teeth and fight cavities. It contains sodium fluoride and acidulated phosphate, which work together to restore enamel and promote oral health. With a refreshing mint flavor, this mouthwash is designed to aid in the prevention of dental cavities, making it a helpful addition to your daily oral care routine.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues. Regular use can be an effective way to maintain a healthy smile and keep your teeth strong.

Dosage and Administration

After brushing your teeth, you can use this mouth rinse twice a day. For adults and children aged 6 years and older, take 10 mL of the rinse and swish it vigorously between your teeth for one 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 helping a child under 12, make sure to teach them how to rinse properly to prevent swallowing the rinse. You should supervise younger children until they can rinse without help. 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 cautious when using this product. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately. This ensures your safety and well-being.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. Always use it as directed to avoid any potential issues.

Side Effects

You can feel reassured that there are no adverse reactions or specific warnings associated with this medication. This means that, based on current information, it is considered safe for use without significant concerns regarding side effects. Always consult with your healthcare provider if you have any questions or need further information 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 is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep your medications in a safe place 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

While the information provided does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to approach any medication with caution during pregnancy. Since there are no special precautions mentioned, it is advisable to consult with your healthcare provider before starting or continuing any medication if you are pregnant or planning to become pregnant. Your healthcare provider can help you weigh the benefits and risks based on your specific situation.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into breast milk, so caution is recommended.

The effects on your nursing infant have not been thoroughly studied, which means you should carefully weigh the potential risks against the benefits of using this product while breastfeeding. Your healthcare provider can help you make an informed decision that is best for you and your baby.

Pediatric Use

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

For children aged 6 years and older, the rinse can be used twice daily after brushing their teeth. They should swish 10 mL of the rinse between their teeth for one minute and then spit it out, making sure not to swallow it. It's also essential to avoid eating or drinking for 30 minutes after rinsing. If your child is under 12, you should guide them on proper rinsing techniques to help prevent swallowing, and supervise them until they can rinse independently. For children under 6 years old, it's best to 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, 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. Specifically, if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste), you should be closely monitored by your healthcare provider.

Before starting treatment, your renal function will be tested, and these tests should continue periodically throughout your treatment. If you have moderate to severe renal impairment, a lower dose of the medication is recommended to ensure your safety and effectiveness of the treatment. Always discuss any concerns with your doctor to ensure the best care for your kidney health.

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. 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° and 25°C (68°–77°F). This temperature range helps maintain its effectiveness. If you notice any cloudiness during cold weather, don’t worry; this is a temporary condition and should resolve once the product returns to room temperature.

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 safety.

Additional Information

You should take this medication orally, twice a day, after brushing your teeth with toothpaste. If you are giving this medication to children under 12, make sure to teach them good rinsing habits to help prevent swallowing it. It's also important to supervise younger children until they can use the medication safely on their own.

FAQ

What is CAREONE®?

CAREONE® is an anti-cavity mouthwash that compares to Listerine® Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

How does CAREONE® help my teeth?

It helps strengthen teeth to fight cavities and restore enamel.

What is the recommended usage for adults and children over 6?

Use twice daily after brushing your teeth, swishing 10 mL of rinse for 1 minute before spitting it out. Do not swallow the rinse and avoid eating or drinking for 30 minutes after rinsing.

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

Get medical help or contact a Poison Control Center immediately.

Is CAREONE® safe for children under 6?

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

Are there any adverse reactions associated with CAREONE®?

No adverse reactions are listed for this product.

What precautions should nursing mothers take?

Nursing mothers should consult a healthcare professional before using this product, as it may be excreted in breast milk.

How should I store CAREONE®?

Store at controlled room temperature between 20°-25°C (68°–77°F).

Are there any specific warnings for using CAREONE®?

Keep out of reach of children and seek medical help if more than the recommended amount is swallowed.

Packaging Info

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

Packaging configurations for Anticavity.
Details

Drug Information (PDF)

This file contains official product information for 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 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 twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 mL 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. Additionally, 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 demonstrates the ability to use the rinse independently and safely.

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

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if more than the recommended amount for rinsing is accidentally swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

For this product, it is imperative to adhere to the following warnings and precautions to ensure safe usage.

In the event of accidental ingestion beyond the recommended amount 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. This precaution is critical to mitigate potential adverse effects associated with excessive consumption.

Healthcare providers should remain vigilant and educate patients on the importance of using the product strictly as directed to prevent any incidents of misuse.

Side Effects

No adverse reactions have been reported in clinical trials or postmarketing experiences. Additionally, there are no specific warnings associated with the use of this product.

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 (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 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, immediate medical assistance or contact with a Poison Control Center is advised.

For pediatric patients aged 6 years and older, the recommended usage is twice daily following tooth brushing. Patients should vigorously swish 10 mL of the rinse between their teeth for 1 minute and then spit it out. It is important that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes after rinsing. Children under 12 years of age should be guided in proper rinsing techniques to minimize the risk of swallowing, and supervision is recommended until they are capable of using the product independently.

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

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, and no special precautions regarding the use of this medication during pregnancy have been included. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential that patients with reduced creatinine clearance are closely monitored throughout their treatment. Renal function tests should be performed prior to the initiation of therapy and periodically during treatment to assess any changes in kidney function. For patients with moderate to severe renal impairment, a reduced dose is recommended to mitigate potential risks associated with decreased renal clearance.

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 alterations in consciousness, respiratory distress, cardiovascular instability, and other systemic effects.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and clinical status, and initiate supportive care as necessary. It is crucial to gather a detailed history of the substance involved, including the amount and route of administration, to guide further management.

Management of overdose may involve the use of specific antidotes, supportive measures, and symptomatic treatment. Healthcare providers should consult relevant clinical guidelines and toxicology resources to determine the most appropriate interventions based on the specific circumstances of the overdose.

In all cases, prompt communication with poison control centers or toxicology specialists is advised to ensure optimal management of the patient. Continuous monitoring and reassessment of the patient’s condition are critical to address any evolving symptoms or complications that may arise during the course of treatment.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount for rinsing is accidentally swallowed. It is important for patients to understand the potential risks associated with improper use of the product and to act promptly in such situations to ensure their safety.

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° to 25°C (68° 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 is capable of using the product independently.

Drug Information (PDF)

This file contains official product information for 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 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.