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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
61596-803

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 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 product is particularly useful for individuals looking to maintain their oral health and protect against dental issues.

Uses

You can use this product to help prevent dental cavities. It works by strengthening your teeth and making them more resistant to decay. It's important to maintain good oral hygiene alongside using this product for the best results.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for most users.

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 provide extra protection for your teeth.

If you have a child under the age of 12, make sure to consult with their dentist or doctor for specific instructions on how to use MI Paste Plus safely.

What to Avoid

It's important to ensure that any medication you use is kept safe and out of reach of children, especially those under 6 years of age. While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication, always prioritize safety by following these guidelines. If you have any questions or concerns about using this medication, consult your healthcare provider for personalized advice.

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 case of accidental swallowing of more than the amount used 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 proteins 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

Currently, there is no information available about the use of MIPaste Plus Tutti Frutti during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert. If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using this product to ensure it is safe for you and your baby.

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 could be passed into your breast milk, which means you should be cautious when considering its use.

Currently, the safety of this product during breastfeeding has not been confirmed, so it’s essential to weigh the potential risks and benefits with your doctor to ensure the well-being of both you and your baby.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old to ensure their safety. For children aged 12 and older, you should encourage them to brush their teeth with their regular toothpaste at least twice a day, or follow the advice of their dentist or doctor. If your child is under 12, it's best to consult with their dental professional or doctor before use to ensure it's appropriate for them.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns or questions with your doctor, especially regarding potential interactions with other medications or existing health conditions.

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 kidney health 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).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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. Following these simple guidelines will help you use the product safely and effectively.

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 used for?

MI Paste Plus aids in the prevention of dental cavities.

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

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?

Consult your dental professional or doctor before use.

Are there any contraindications for MI Paste Plus?

There are no listed contraindications, but do not use it on patients with a milk protein or hydroxybenzoates allergy.

What precautions should I take when using MI Paste Plus?

Keep MI Paste Plus out of reach of children under 6 years of age, and in case of an allergic reaction, stop use and seek medical advice.

Is MI Paste Plus safe to use during pregnancy?

There is no information regarding the safety of MI Paste Plus during pregnancy; consult your healthcare provider.

Can nursing mothers use MI Paste Plus?

Nursing mothers should consult their healthcare provider before using MI Paste Plus, as there is a potential for excretion in breast milk.

How should MI Paste Plus be stored?

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

Packaging Info

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

Packaging configurations for Mipaste Plus Tutti Frutti.
Details

Drug Information (PDF)

This file contains official product information for Mipaste Plus Tutti Frutti, 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, the mouth should be rinsed 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 be allowed to 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.

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.

Patients with known allergies to milk protein or hydroxybenzoates should not use this product, as it may provoke an allergic reaction. In the event of an allergic reaction, it is crucial to discontinue use immediately, rinse the mouth with water, and seek medical advice promptly.

In cases of accidental ingestion of an amount greater than what is typically used for brushing, it is essential to obtain medical assistance or contact a Poison Control Center without delay. This precaution is vital to ensure the safety and well-being of the patient.

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 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 Mipaste Plus Tutti Frutti. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mipaste Plus Tutti Frutti.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this product. For children aged 12 years and older, it is recommended to brush teeth with normal toothpaste at least twice a day, or as directed by a dental professional or doctor. For children under the age of 12, consultation with a dental professional 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of MIPaste Plus Tutti Frutti during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should exercise caution when prescribing this product to pregnant patients, as the lack of data precludes a comprehensive assessment of potential risks to fetal outcomes. Women of childbearing potential should be informed of the absence of safety data and encouraged to discuss any concerns with their healthcare provider.

Lactation

Lactating 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 safety of this product during lactation has not been established.

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 clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the recommended amount 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 related to excessive ingestion is essential, although specific symptoms are not detailed in the provided information.

Management of overdosage should focus on supportive care and symptomatic treatment as necessary. It is advisable for healthcare providers to follow established protocols for handling cases of overdosage, ensuring that appropriate measures are taken to safeguard the patient's health.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include rash, urticaria, and angioedema.

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 a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Mipaste Plus Tutti Frutti, 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 Tutti Frutti, 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.