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Anticavity 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 2010
Label revision date
February 6, 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 2010
Label revision date
February 6, 2026
Manufacturer
Retail Business Services, LLC
Registration number
M021
NDC root
72476-204
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

CAREONE® is a children's anticavity fluoride rinse designed to help prevent dental cavities. This alcohol-free mouthwash comes in a fun bubble gum flavor, making it appealing for kids while providing strong cavity protection. By using this rinse, you can support your child's dental health and help keep their smiles bright.

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. Keeping your teeth healthy is essential for maintaining a bright smile and overall well-being.

Dosage and Administration

To use this mouth rinse effectively, you should apply it 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 not to 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 they understand how to rinse properly 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 may experience some adverse reactions when using this product. It's important to be aware of these potential side effects. If you notice anything unusual or concerning, please consult a healthcare professional.

Additionally, there are specific warnings associated with this product that you should consider. Always read the information provided and reach out to a healthcare provider if you have any questions or concerns about your health while using it.

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 is 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. While there are no specific contraindications listed, caution is advised since the effects on fetal development are not well studied. Currently, there is no detailed information available regarding potential risks to the fetus, and no dosage modifications for pregnant individuals have been specified.

Before using this product, it is essential to consult with your healthcare provider to discuss any concerns and ensure it is safe for you and your baby. Your health and the health of your developing child should always come first.

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 a child accidentally swallows more than what is needed for rinsing, you should 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 prevent swallowing. Always supervise younger children until they can 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 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. This is because renal impairment (reduced kidney function) can affect how your body processes certain drugs. To ensure your safety and the effectiveness of your treatment, your healthcare provider will monitor your kidney function regularly.

Before starting any new therapy, you should have tests done to check your renal function, specifically looking at creatinine clearance levels (a measure of how well your kidneys are filtering waste). These tests will also be repeated periodically to keep track of any changes in your kidney health. Always discuss any concerns with your healthcare provider to ensure your treatment plan is appropriate for your needs.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 healthcare provider can help ensure that your treatment is safe and effective. Always discuss any other medications or supplements you are using, as well as any lab tests you may need, to avoid potential issues.

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 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 safety and effectiveness. Always follow any specific instructions provided with the product for optimal use.

Additional Information

You should take this medication orally, once 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's important to supervise younger children until they can use it safely on their own. For children under 6 years old, consult a dentist or doctor before use.

FAQ

What is CAREONE®?

CAREONE® is a children's anticavity fluoride rinse that provides strong cavity protection and comes in a bubble gum flavor. It is alcohol-free and is comparable to Act® Kids Anticavity Fluoride Rinse.

How do I use CAREONE®?

Use CAREONE® once a day after brushing your teeth. Pour 10 milliliters (mL) 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 the recommended amount is swallowed, seek professional assistance or contact a Poison Control Center immediately.

Is CAREONE® safe for children?

Children under 12 years should be instructed in good rinsing habits to minimize swallowing, and they should be supervised until capable of using it without assistance. Consult a dentist or doctor for children under 6 years of age.

Can I use CAREONE® during pregnancy?

The safety of CAREONE® during pregnancy has not been established, so consult a healthcare provider if you are pregnant or planning to become pregnant before using this product.

Are there any contraindications for using CAREONE®?

No specific contraindications are listed, but caution is advised, especially for pregnant individuals due to limited studies on fetal development.

How should I store CAREONE®?

Store CAREONE® at room temperature.

What should I do if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and your renal function should be monitored regularly.

Packaging Info

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

Packaging configurations for Anticavity Rinse.
Details

Drug Information (PDF)

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

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 allow for 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 rinse 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, it is essential to seek professional assistance or contact a Poison Control Center immediately.

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, it is recommended that the patient discontinue use and consult their healthcare provider for further evaluation and guidance.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. While specific adverse reactions have not been detailed in the provided information, it is important to note that warnings are included for this product.

In clinical practice, healthcare providers should monitor patients for any unexpected symptoms or reactions following the use of this product. Participants in clinical trials and postmarketing experiences may provide additional insights into the safety profile, although specific data is not available in the current documentation.

For any concerns regarding adverse reactions, patients are encouraged to contact their healthcare provider or the distributor, Foodhold, U.S.A, LLC, at 1-877-846-9949. Quality is guaranteed, and patients may seek a refund if they are not satisfied with the 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 Rinse (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Anticavity 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

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. Caution is advised as the effects on fetal development are not well studied, and no specific information regarding risks to the fetus is provided. Healthcare providers should be consulted if a patient is pregnant or planning to become pregnant before using this product. There are no specific dosage modifications for pregnant individuals mentioned in the available data.

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

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels. Additionally, renal function tests are recommended prior to initiating therapy and should be conducted periodically thereafter for patients with known renal impairment.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse effects that may arise. In the event of suspected overdosage, it is recommended to initiate supportive care and symptomatic treatment as necessary.

Healthcare providers should consider contacting a poison control center for guidance on management strategies tailored to the specific situation. Continuous assessment of the patient's clinical status is essential to ensure appropriate interventions are implemented promptly.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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 efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of once daily for adults and children aged 6 years and older, 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 of age, consultation with a dentist or doctor is advised.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Anticavity 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 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

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.