ADD CONDITION

items per page

Mouth Rinse

Last content change checked dailysee data sync status

Active ingredient
Sodium Fluoride 0.1 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 13, 2026
Active ingredient
Sodium Fluoride 0.1 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 13, 2026
Manufacturer
Topco Associates LLC
Registration number
M021
NDC root
36800-001

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

TopCare is an anticavity mouthwash designed to help you maintain good oral health. It aids in the prevention of dental cavities, strengthens teeth, and restores enamel, which is the protective outer layer of your teeth. Additionally, TopCare kills bad breath germs, freshens your breath, and cleans your entire mouth, making it a helpful addition to your daily oral care routine.

This mouthwash contains sodium fluoride and acidulated phosphate topical solution, which work together to enhance its effectiveness. With a refreshing eucalyptus mint flavor, TopCare is a convenient way to support your dental hygiene, although it is important to remember that it should not replace regular brushing and flossing.

Uses

Using this product can be beneficial for your dental health in several ways. It helps prevent dental cavities, which are holes in your teeth caused by decay. By using it regularly, you can strengthen your teeth and restore enamel, the protective outer layer of your teeth that can wear down over time.

In addition to cavity prevention, this product also works to kill germs that cause bad breath, leaving your mouth feeling fresh and clean. It effectively cleans your entire mouth, ensuring that you maintain good oral hygiene.

Dosage and Administration

After brushing your teeth, 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 one minute before spitting it out. It's important not to swallow the rinse. After using it, avoid eating or drinking anything for 30 minutes to allow the rinse to work effectively.

If you're helping a child under 12 years old, make sure to teach them how to rinse properly to prevent swallowing the rinse. You should supervise them until they can use it on their own. If the 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 this product as directed.

Side Effects

You may not experience any specific adverse reactions or warnings associated with this medication, as none have been listed. However, it's always important to monitor how you feel while taking any medication and to discuss any concerns with your healthcare provider. If you notice anything unusual, be sure to reach out for guidance.

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, 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

The safety of this product during pregnancy has not been established, which means that it may not be safe for you or your developing baby. Because of potential risks to the fetus, it is advised that you do not use this product while pregnant.

If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using this product. They can provide guidance and help you understand any potential risks involved.

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. This means that, based on the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

However, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about medications or products you are considering while breastfeeding. They can provide personalized advice based on your individual situation.

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 under 12 years old, it's best to consult with a dentist or doctor before use. If approved, ensure they use the rinse twice daily after brushing their teeth with toothpaste. They should swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for one minute and then spit it out, without swallowing. Make sure to supervise them during this process to help them develop good rinsing habits and avoid swallowing the rinse. Additionally, remind them not to eat or drink anything for 30 minutes after rinsing.

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 always wise to discuss any medications with a healthcare provider, especially since older individuals may have different health needs and responses to treatments.

Since there are no dosage adjustments or safety concerns specifically noted for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your kidneys may not process the drug as effectively, which can lead to higher levels of the medication in your body. Regular monitoring of your kidney function is essential, and this is often done by checking your creatinine clearance (a measure of how well your kidneys are filtering waste).

Depending on the severity of your kidney impairment, specific recommendations for reducing your dosage will be provided. Always keep in mind that with compromised kidney function, there is a risk of increased drug accumulation, which can lead to potential safety concerns. Make sure to discuss your kidney health with your healthcare provider to ensure you are receiving the appropriate care.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

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 of your product, store it at a controlled room temperature between 20°C and 25°C (68°F and 77°F). This temperature range helps maintain its effectiveness. Be aware that if the product is exposed to cold weather, it may temporarily appear cloudy, but this does not affect its safety or function.

Handle the product with care, and always ensure that it is stored properly to avoid any potential issues. If you have any questions about disposal or specific handling instructions, please refer to the guidelines provided with your product.

Additional Information

You should take this medication orally. If you are giving it to children under 12 years old, it's important to teach them good rinsing habits to help prevent swallowing the medication. Make sure to supervise them until they can use it safely on their own. Additionally, if the child is under 12, consult a dentist or doctor for further guidance.

FAQ

What is TopCare?

TopCare is an anticavity mouthwash that aids in the prevention of dental cavities and helps strengthen teeth.

How should I use TopCare mouthwash?

Use TopCare twice daily after brushing your teeth. Vigorously swish 10 mL (2 teaspoonfuls) between your teeth for 1 minute, then spit it out.

Can children use TopCare mouthwash?

Children under 12 years of age should consult a dentist or doctor before use and should be supervised while rinsing to minimize swallowing.

What should I do if I accidentally swallow TopCare mouthwash?

If more than the recommended amount is swallowed, get medical help or contact a Poison Control Center immediately.

Is TopCare safe to use during pregnancy?

The safety of TopCare during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What are the key benefits of using TopCare?

TopCare helps prevent cavities, strengthens teeth, restores enamel, kills bad breath germs, and freshens breath.

What should I avoid after using TopCare mouthwash?

Do not eat or drink anything for 30 minutes after rinsing with TopCare.

How should TopCare be stored?

Store TopCare at controlled room temperature between 20⁰ - 25⁰C (68⁰ - 77⁰ F).

Packaging Info

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

Packaging configurations for Mouth Rinse.
Details

Drug Information (PDF)

This file contains official product information for Mouth 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 and the strengthening of teeth. It aids in restoring enamel and effectively kills germs that cause bad breath, while also freshening breath and cleaning the entire mouth.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to use the rinse twice daily, following brushing with a 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 use of the rinse to ensure optimal efficacy. For children under 12 years of age, it is essential 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 their use until they are capable of performing the task independently.

Contraindications

Use is contraindicated if more than the recommended amount for rinsing is accidentally swallowed. In such cases, seek medical assistance or contact a Poison Control Center immediately.

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 prescribed usage guidelines to mitigate the risk of 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

There are no specific adverse reactions or warnings associated with the use of the product as indicated in the provided data. Therefore, no adverse reactions have been documented in clinical trials or postmarketing experiences. 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 Mouth Rinse (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mouth 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 recommended usage is twice daily following tooth brushing. Patients should vigorously swish 10 mL (2 teaspoonfuls) of the rinse between their teeth for 1 minute before spitting it out. It is important that the rinse is not swallowed, and patients should refrain from eating or drinking for 30 minutes after rinsing.

For children under 12 years of age, it is essential to consult a dentist or doctor prior to use. Caregivers should instruct children in proper rinsing techniques to minimize the risk of swallowing the rinse and should supervise their use until they are capable of rinsing without assistance.

Geriatric Use

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of this product during pregnancy has not been established. Use of this product is contraindicated in pregnancy due to potential risks to the fetus. Pregnant women should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or its effects on breastfed infants.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor renal function regularly in patients with reduced kidney function.

Dosage adjustments should be based on creatinine clearance levels, with specific recommendations for dosage reduction provided for patients with varying degrees of renal impairment. Safety considerations must be taken into account, as there is a potential for increased drug accumulation in patients with compromised kidney function.

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 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. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any concerning signs or symptoms develop, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

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 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 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°C to 25°C (68°F to 77°F).

It is important to note that exposure to cold weather may cause temporary cloudiness in the product. Therefore, care should be taken to avoid storage conditions that may lead to such exposure.

Additional Clinical Information

The medication is administered orally. Clinicians should instruct parents or guardians to teach children under 12 years of age proper rinsing habits to minimize swallowing. Supervision is recommended until the child is capable of using the medication without assistance. Additionally, it is advised that parents consult a dentist or doctor regarding the use of this medication in children under 12 years.

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

Drug Information (PDF)

This file contains official product information for Mouth 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 Mouth 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.