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Plaque Refresh Remineralizing Rinse Fresh Mint

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Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
May 30, 2025
Active ingredient
Sodium Fluoride 0.1 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
May 30, 2025
Manufacturer
TJA Health LLC
Registration number
M021
NDC root
57660-003

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Drug Overview

This medication is designed to help prevent dental cavities, which are small holes in your teeth caused by decay. By using this product, you can support your oral health and reduce the risk of developing cavities, contributing to a healthier smile. It's an important tool in maintaining good dental hygiene and overall well-being.

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.

Dosage and Administration

For adults and children aged 12 and older, you should use the mouth rinse twice a day after brushing your teeth. To do this, measure out 10 mL (which is about 2 teaspoonfuls) of the rinse. Vigorously swish it between your teeth for 1 minute, then spit 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 have children under 12, it's best to consult a dentist or doctor before using this mouth rinse. Make sure to supervise younger children as needed to ensure they use the rinse safely.

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 or dependence, you should take care when using it.

If you accidentally swallow more than what is intended for rinsing, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please follow these guidelines closely.

Side Effects

Using this medication may lead to some side effects. If you accidentally swallow more than what is intended for rinsing, it’s important to seek medical help or contact a Poison Control Center immediately.

Always be aware of how you use the product to avoid any potential risks. If you experience any unusual symptoms or reactions, consult your healthcare provider for guidance.

Warnings and Precautions

If you accidentally swallow more of this product than intended for rinsing, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and address any potential risks.

Currently, there are no specific general precautions or laboratory tests associated with this product. However, always stay informed and consult with your healthcare provider if you have any concerns or questions about its use.

Overdose

If you accidentally swallow more of this product than intended for rinsing, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose can vary, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available about the safety or use of this medication during pregnancy. This means that there are no established guidelines regarding dosage adjustments or special precautions for pregnant individuals.

Given this lack of information, it's crucial to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

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 medications while breastfeeding.

Pediatric Use

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

For adults and children aged 12 and older, the recommended use is twice daily after brushing your teeth. However, if your child is under 12 years old, it's best to consult with a dentist or doctor before use to ensure safety and proper guidance.

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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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 provided 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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always share your complete list of medications and any lab tests you may be undergoing to avoid any 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 around 68°F to 77°F (20°C to 25°C). If you notice any cloudiness in the product during cold weather, don’t worry; this is a temporary condition and should clear up once the product returns to room temperature.

Always handle the product with care to maintain its quality and effectiveness. Make sure to follow any additional safety instructions provided with the product to ensure safe usage and disposal.

Additional Information

You should use this product topically, applying it twice daily after brushing your teeth. It's important not to swallow the rinse; if you accidentally swallow more than intended, seek medical help or contact a Poison Control Center immediately. Additionally, avoid eating or drinking for 30 minutes after rinsing to ensure the product works effectively. If children are using this product, make sure to supervise them as needed.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of dental cavities.

How should adults and children 12 years or older use this product?

Use twice daily after brushing your teeth by vigorously swishing 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute, then spit it out. Do not swallow the rinse and avoid eating or drinking for 30 minutes after rinsing.

What should children under 12 years of age do?

Consult a dentist or doctor before use.

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

Get medical help or contact a Poison Control Center right away.

Are there any contraindications for this drug?

No contraindications are listed.

Is this drug safe for nursing mothers?

There are no specific warnings or recommendations regarding its use by nursing mothers.

How should I store this product?

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

What precautions should I take when using this product?

Keep it out of reach of children and supervise children as necessary during use.

Packaging Info

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

Packaging configurations for Plaque Refresh Remineralizing Rinse Fresh Mint.
Details

Drug Information (PDF)

This file contains official product information for Plaque Refresh Remineralizing Rinse Fresh Mint, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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 12 years of age or older are instructed to use the rinse twice daily, following tooth brushing. 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. Additionally, patients should refrain from eating or drinking for 30 minutes following the rinsing procedure to maximize efficacy.

For children under 12 years of age, it is advised to consult a dentist or doctor prior to use. Caregivers should supervise the administration of the rinse to ensure safety and proper technique.

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

If more than the recommended amount for rinsing is accidentally ingested, immediate medical assistance should be sought. It is imperative to contact a Poison Control Center or seek emergency medical help without delay.

No specific general precautions or laboratory tests have been identified for this product. Healthcare professionals should remain vigilant and ensure that patients are aware of the potential risks associated with accidental ingestion.

Side Effects

Patients may experience various side effects associated with the use of this product. In the event that more than the recommended amount intended for rinsing is accidentally ingested, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

It is essential for healthcare providers to be aware of these potential adverse reactions to ensure patient safety and appropriate management in case of an overdose.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Plaque Refresh Remineralizing Rinse Fresh Mint.
Details

Pediatric Use

Pediatric patients should be kept 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 dosing, adults and children aged 12 years and older are instructed to use the product twice daily after brushing their teeth. For children under 12 years of age, it is recommended to consult a dentist or doctor 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

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 any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available 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.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

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 provided 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 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 topically, with a recommended frequency of twice daily following tooth brushing. Clinicians should advise patients not to swallow the rinse and to refrain from eating or drinking for 30 minutes after use. In cases where more than the recommended amount is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately. Additionally, supervision of children during use is advised to ensure safety.

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

Drug Information (PDF)

This file contains official product information for Plaque Refresh Remineralizing Rinse Fresh Mint, 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 Plaque Refresh Remineralizing Rinse Fresh Mint, 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.