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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)
Marketed in the U.S.
Since 2024
Label revision date
February 13, 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 2024
Label revision date
February 13, 2026
Manufacturer
Topco Associates LLC
Registration number
M021
NDC root
76162-838

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Drug Overview

TopCare Kids Anticavity Fluoride Oral Rinse is a watermelon-flavored mouthwash designed specifically for children. This oral rinse helps prevent dental cavities and strengthens teeth, making it a useful addition to your child's oral hygiene routine.

Formulated without dyes, parabens, alcohol, or sugar, it offers a gentle yet effective way to support your child's dental health.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By using it regularly, you not only work to keep cavities at bay but also strengthen your teeth, making them more resilient against damage. This can contribute to better overall oral health and a brighter smile.

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 (which is marked on the inside of the cap) into the cap. Make sure not to fill above the 10 milliliter mark.

Next, vigorously swish the 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 they understand how to rinse properly to avoid 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, misuse, 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 right away. Your safety is paramount, so always use the product as directed.

Side Effects

You may experience some adverse reactions while using this medication. It's important to be aware of these potential side effects, even though specific details were not provided in the available information.

If you notice any unusual symptoms or reactions, please consult your healthcare provider for guidance. Staying informed about how your body responds to the medication can help ensure your safety and well-being.

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, you should seek emergency medical help right away or contact a Poison Control Center.

While there are no specific general precautions or laboratory tests mentioned, always use the product as directed to ensure your safety. If you have any concerns or experience unusual symptoms, it's best to stop using the product and consult your doctor for further advice.

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 potential risks associated with taking more than the recommended dose. If you suspect an overdose, look out for any unusual symptoms or changes in your health.

In the event of an overdose, it is crucial to seek immediate medical attention. You can contact your local emergency services or go to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to be safe and get help right away.

Pregnancy Use

The safety of this product during pregnancy has not been established, so it's important to approach its use with caution. While there are no specific contraindications listed, the effects on fetal development are not well studied, which means potential risks to the fetus are unclear.

If you are pregnant or planning to become pregnant, it is crucial to consult your healthcare provider before using this product. They can provide personalized advice and help you weigh the potential benefits and risks.

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 before making a decision. Your healthcare provider can help you navigate these considerations to ensure the best outcome for both you and your baby.

Pediatric Use

It's important to take special care when using this product for children. If your child is under 6 years old, you should consult a dentist or doctor before use. For children under 12, make sure to teach them good rinsing habits to help prevent swallowing the product. Always supervise younger children until they are able to use it safely on their own.

For children aged 6 and older, the product can be used once a day after brushing their teeth with toothpaste. This helps ensure they get the benefits while minimizing any risks.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine if this medication is appropriate for you, considering any unique health needs or conditions.

Always keep in mind that older adults may have different responses to medications, so monitoring for any side effects or changes in health is essential. If you notice anything unusual after starting a new medication, be sure to reach out to a healthcare professional for guidance.

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 (kidney issues) can affect how your body processes certain drugs. To ensure your safety, your healthcare provider will monitor your creatinine clearance (a test that measures how well your kidneys are filtering waste) regularly.

Additionally, regular renal function tests are essential to keep track of your kidney health. If you have significant renal impairment, special monitoring will be necessary to manage your treatment effectively. Always communicate with your healthcare team about your kidney function to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This means that your healthcare provider might change how much of the medication you take to ensure it's safe and effective for you. Additionally, special monitoring of liver function tests (which are blood tests that check how well your liver is working) is recommended to keep an eye on your liver health while you are on this medication.

Always exercise caution when taking this medication if you have liver dysfunction. Make sure to discuss your liver condition with your healthcare provider, who can guide you on the best approach to your treatment.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. This helps maintain its effectiveness and integrity. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage.

If you have any components that come with the product, make sure to keep them in a clean and safe environment. Always dispose of any used materials according to local regulations to ensure safety and environmental protection.

Additional Information

No further information is available.

FAQ

What is TopCare Kids Anticavity Fluoride Oral Rinse?

TopCare Kids Anticavity Fluoride Oral Rinse is a watermelon-flavored mouth rinse that aids in the prevention of dental cavities and helps strengthen teeth.

How should I use TopCare Kids Anticavity Fluoride Oral Rinse?

Use once a day after brushing your teeth. Pour 10 milliliters of rinse, swish it between your teeth for 1 minute, and then spit it out. Do not swallow the rinse.

What should I do if more than the recommended amount is swallowed?

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

Is TopCare Kids Anticavity Fluoride Oral Rinse safe for children?

It is recommended for adults and children 6 years of age and older. For children under 6 years, consult a dentist or doctor.

Can I use this product during pregnancy?

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

What precautions should nursing mothers take?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

Are there any contraindications for using this rinse?

No specific contraindications are listed, but caution is advised, especially for pregnant individuals.

How should I store TopCare Kids Anticavity Fluoride Oral Rinse?

Store the rinse at room temperature.

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 drug.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It aids in the prevention of cavities and strengthens teeth, contributing to overall oral health.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse once daily, following the brushing of teeth with toothpaste.

To administer, the cap should be removed, and 10 milliliters (10 mL mark on the inside of the cap) should be poured; care should be taken not to exceed the 10 mL mark. The individual should then vigorously swish the 10 milliliters 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 ensure optimal effectiveness of the rinse.

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, seek professional assistance or contact a Poison Control Center immediately.

Warnings and Precautions

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

In the event that more than the recommended amount for rinsing is accidentally ingested, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to manage potential risks associated with ingestion.

While no specific general precautions or laboratory tests are outlined, it is essential for healthcare providers to remain vigilant and monitor patients for any adverse effects or unusual reactions during the use of this product. Regular assessment and communication with patients regarding their experience with the product are recommended to ensure safety and efficacy.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. While specific adverse reactions and warnings were not detailed in the provided information, it is important for healthcare professionals to monitor patients for any unexpected effects during treatment.

In clinical trials, participants should be observed closely for any signs of serious adverse reactions, as well as for common reactions that may arise. Postmarketing experiences may also provide additional insights into the safety profile of the medication, highlighting the importance of ongoing surveillance and reporting of adverse events.

Healthcare providers are encouraged to report any adverse reactions observed in patients to contribute to the overall understanding of the medication's safety and efficacy.

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 under 6 years of age should consult a dentist or doctor prior to use. For children under 12 years of age, it is important to instruct them in proper rinsing habits to minimize swallowing. Supervision is recommended for children until they are capable of using the product without assistance. For adults and children aged 6 years and older, the product is to be used once daily after brushing teeth with toothpaste.

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

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 lactating 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 necessitate dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function. Regular renal function tests should be performed to assess kidney health, and special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with altered pharmacokinetics.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is recommended that liver function tests be monitored closely in this population to ensure safety and efficacy. Caution should be exercised when administering this medication to patients with liver dysfunction, as their altered metabolic capacity may affect drug clearance and overall treatment outcomes.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 potential effects in nonclinical settings.

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

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.