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Sodium fluoride

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Active ingredient
Sodium Fluoride 0.2 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
December 19, 2025
Active ingredient
Sodium Fluoride 0.2 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
December 19, 2025
Manufacturer
GC America Inc.
Registration number
M021
NDC root
61596-801

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

MI Paste Plus Mint is a dental product designed to help prevent cavities. It works by providing essential minerals to your teeth, which can strengthen enamel and reduce the risk of decay. This mint-flavored paste is a supportive addition to your oral care routine, especially if you're looking to maintain healthy teeth and gums.

Uses

You can use this product to help prevent dental cavities, which are 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.

It's important to note that this product has not been shown to cause any harmful effects during pregnancy or to have any other adverse effects. This makes it a safe option for maintaining your dental hygiene.

Dosage and Administration

To keep your teeth healthy, it's important to brush them with your regular toothpaste at least twice a day, or as your dentist or doctor recommends. After brushing, rinse your mouth to remove any leftover toothpaste.

Next, take a pea-sized amount of MI Paste Plus and apply it to your finger. Spread it evenly over your upper teeth, then do the same for your lower teeth. Let the paste sit on your teeth for 3 minutes without rinsing it off. This helps to strengthen your teeth and protect them.

If you have children under 12, make sure to consult their dentist or doctor for specific guidance on using MI Paste Plus.

What to Avoid

It's important to keep this medication out of reach of children under 6 years of age to ensure their safety. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

It's important to be aware of some warnings associated with this product. Keep it out of reach of children under 6 years old, and do not use it if you have an allergy to milk protein or hydroxybenzoates. If you experience an allergic reaction, stop using the product immediately, rinse your mouth with water, and seek medical advice.

In the event that you accidentally swallow more than the amount intended for brushing, it's crucial to get medical help or contact a Poison Control Center right away.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. If you have an allergy to milk protein or hydroxybenzoates, you should not use this product.

In the event of an allergic reaction, stop using the product immediately, rinse your mouth with water, and seek medical advice. If you accidentally swallow more than the amount used for brushing, please get medical help or contact a Poison Control Center right away. Your safety is a priority, so always follow these precautions carefully.

Overdose

If you accidentally swallow more of the medication than what is typically used for brushing your teeth, it’s important to seek medical help immediately or contact a Poison Control Center. Overdosing can lead to serious health issues, so don’t hesitate to reach out for assistance.

Signs of an overdose may include unusual symptoms, but it’s crucial to act quickly if you suspect you’ve taken too much. Always prioritize your safety and well-being by getting help right away.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits are not clearly defined.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you understand the best options for your health and the health of your baby. Always prioritize open communication with your doctor regarding any concerns you may have.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare provider 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.

Pediatric Use

It's important to keep this medication out of reach of children under 6 years old to ensure their safety. If your child is under 12 years of age, you should consult with your dental professional or doctor before using this medication. They can provide guidance on whether it's appropriate for your child and what the correct dosage might be. Always prioritize your child's health by seeking professional advice when it comes to medications.

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 your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your condition and make any necessary adjustments to your medications.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market. If you have any questions about how this medication works or its specific use, be sure to consult your healthcare provider.

FAQ

What is MI Paste Plus Mint used for?

MI Paste Plus Mint aids in the prevention of dental cavities.

How should adults and children over 12 use MI Paste Plus Mint?

Brush your teeth with your normal toothpaste at least twice a day, rinse your mouth after brushing, and apply a pea-sized portion of MI Paste Plus thoroughly on your teeth, allowing it to remain for 3 minutes without rinsing.

What should children under 12 do before using MI Paste Plus Mint?

Consult your dental professional or doctor before use.

Are there any contraindications for MI Paste Plus Mint?

There are no contraindications listed for MI Paste Plus Mint.

What precautions should be taken regarding children and MI Paste Plus Mint?

Keep MI Paste Plus Mint out of reach of children under 6 years of age.

What should I do if I have an allergic reaction to MI Paste Plus Mint?

Stop use immediately, rinse your mouth with water, and seek medical advice.

Is there any information about using MI Paste Plus Mint during pregnancy?

No specific information regarding pregnancy use or safety concerns is provided; consult your healthcare provider.

Can nursing mothers use MI Paste Plus Mint?

Nursing mothers should consult their healthcare provider before use, as there is potential for excretion in breast milk.

How should MI Paste Plus Mint be stored?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Mipaste Plus Mint. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mipaste Plus Mint.
Details

Drug Information (PDF)

This file contains official product information for Mipaste Plus Mint, 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.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children over the age of 12 should brush their teeth with their normal toothpaste at least twice daily, or as directed by their dental professional or doctor. Following brushing, they should rinse their mouth thoroughly. A pea-sized portion of MI Paste Plus should be dispensed onto a finger and applied thoroughly, ensuring an even layer coats the upper teeth. This process should be repeated for the lower teeth. The paste should remain on the teeth for a duration of 3 minutes without rinsing.

For children under the age of 12, it is recommended to consult a dental professional or doctor for appropriate guidance on usage.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm due to the product's formulation or effects in this age group. Additionally, it is advised to keep the product out of reach of children to ensure safety.

Warnings and Precautions

It is imperative to keep this product out of reach of children under 6 years of age to prevent accidental ingestion and potential harm.

This product is contraindicated in patients with known allergies to milk protein or hydroxybenzoates. Healthcare professionals should ensure that patients are screened for these allergies prior to use.

In the event of an allergic reaction, it is crucial to discontinue use immediately. Patients should rinse their mouth thoroughly with water and seek medical advice without delay.

If an accidental ingestion occurs, particularly if more than the recommended amount for brushing is swallowed, it is essential to obtain medical assistance or contact a Poison Control Center immediately. Prompt action is necessary to mitigate any potential adverse effects.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. The product should not be used in patients with known allergies to milk protein or hydroxybenzoates, as this may lead to adverse reactions.

In the event of an allergic reaction, patients are advised to discontinue use immediately, rinse the mouth with water, and seek medical advice. Additionally, if a patient accidentally swallows more than the amount intended for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay. These precautions are essential to ensure the safety and well-being of patients using 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 Mipaste Plus Mint. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mipaste Plus Mint.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this medication. For children under the age of 12, it is recommended to consult a dental professional or doctor prior to use to ensure safety and appropriateness of treatment.

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

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

Nursing mothers should consult their healthcare provider 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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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

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

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential. It is recommended that healthcare providers familiarize themselves with local Poison Control resources to ensure rapid access to expert guidance in such situations.

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 provided in the insert for MIPASTE PLUS MINT.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The route of administration for the medication is dental. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mipaste Plus 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 Mipaste Plus 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.