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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
61596-802

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If you are a consumer or patient please visit this version.

Drug Overview

MI Paste Plus Vanilla is a dental product designed to help prevent cavities. It works by providing essential minerals to your teeth, which can strengthen enamel and support overall oral health. This product is particularly beneficial for individuals looking to enhance their dental care routine and reduce the risk of tooth decay.

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.

Rest assured, this product does not have any known teratogenic effects (which means it does not cause birth defects) or nonteratogenic 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 with their dentist or doctor for specific guidance on using MI Paste Plus.

What to Avoid

It's important to ensure that any medication you use is kept safe, especially around children. You should always keep this medication out of reach of children under 6 years of age to prevent any accidental ingestion or misuse.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always consult with your healthcare provider if you have any questions or concerns about its use.

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 proteins or hydroxybenzoates. If you experience an allergic reaction, which can include symptoms like rash or difficulty breathing, 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 used for brushing, it's crucial to get medical help or contact a Poison Control Center right away. Always prioritize your safety and well-being when using any medication or product.

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 product 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 not always be obvious, but if you experience any unusual symptoms after swallowing too much, it’s crucial to get help right away. Remember, your safety is the top priority, and getting prompt medical attention can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information provided does not specify any safety concerns related to the use of this medication during pregnancy. There are no recommended dosage modifications for pregnant individuals, and no special precautions are noted for its use in this context.

As always, it's best to consult with your healthcare provider about any medications you are considering or currently taking to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of MIPaste Plus Vanilla for nursing mothers. Additionally, there is no information indicating that this product is excreted in breast milk or that it poses any risk to your infant while you are lactating. Always consult with your healthcare provider if you have any concerns or questions about using new products while breastfeeding.

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 how to use it safely. 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 a 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 healthcare team are essential to 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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 postmarketing experiences. If you have any questions about how this medication works or its specific use, be sure to consult your healthcare provider for more information.

FAQ

What is MI Paste Plus Vanilla used for?

MI Paste Plus Vanilla 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 contraindications listed for MI Paste Plus.

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 do not use it if you have a milk protein or hydroxybenzoates allergy.

What should I do in case of an allergic reaction to MI Paste Plus?

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

What should I do if I accidentally swallow MI Paste Plus?

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

Is MI Paste Plus safe to use during pregnancy?

There are no specific safety concerns or dosage modifications regarding the use of MI Paste Plus during pregnancy mentioned.

Can nursing mothers use MI Paste Plus?

There are no specific warnings or recommendations regarding the use of MI Paste Plus in nursing mothers.

How should I store MI Paste Plus?

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

Packaging Info

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

Packaging configurations for Mipaste Plus Vanilla.
Details

Drug Information (PDF)

This file contains official product information for Mipaste Plus Vanilla, 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, as the safety and efficacy of the product have not been established in this age group. Additionally, it is advised to keep the product out of reach of children to avoid accidental ingestion or misuse.

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 with water and seek medical advice promptly to address any adverse effects.

If an accidental ingestion occurs, particularly if more than the recommended amount for brushing is swallowed, it is essential to seek 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 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 Vanilla. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mipaste Plus Vanilla.
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 advised to consult a dental professional or doctor prior to use.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been noted. There are no dosage modifications required for pregnant individuals, and no special precautions regarding the use of this medication during pregnancy are included in the prescribing information. Healthcare professionals should continue to monitor the overall health and well-being of pregnant patients while considering the use of this medication.

Lactation

There are no specific warnings or recommendations regarding the use of MIPaste Plus Vanilla in lactating mothers. Additionally, there is no information available about the potential for excretion of MIPaste Plus Vanilla in breast milk or any associated risks to breastfed infants.

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 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 the clinical presentation is essential.

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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert for MIPASTE PLUS VANILLA.

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 ensure that patients understand the necessity of proper storage to prevent such incidents.

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 product is dental. There are no additional details available regarding laboratory tests, abuse information, patient counseling information, or postmarketing experience.

Drug Information (PDF)

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