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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
61596-804

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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 support overall oral health. This can be particularly beneficial for individuals at higher risk of developing dental cavities, helping to maintain a healthy smile.

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 does not have any known teratogenic effects (which means it doesn't 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. Carefully spread it over your upper teeth, making sure to cover them evenly, and then do the same for your lower teeth. Once applied, let the paste sit on your teeth for 3 minutes without rinsing.

If you have a child under 12, it's best to consult with their dentist or doctor for specific guidance on using MI Paste Plus. Remember, this process should be done at least twice a day to help maintain good oral health.

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 or concerns about abuse, misuse, or dependence associated with this medication, always prioritize safety by following this guideline. 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. 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 it immediately, rinse your mouth with water, and seek medical advice. If you accidentally swallow more than the amount used for brushing, contact a medical professional or 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 take these precautions seriously.

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

While the information provided does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to approach any medication with caution during pregnancy. Since there are no special precautions mentioned, you should consult with your healthcare provider before taking any medication to ensure it is safe for you and your baby. Your healthcare provider can offer personalized advice based on your specific situation and health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

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's specific needs. Always prioritize your child's health and safety by seeking professional advice when necessary.

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, it’s important to consult with a healthcare provider before starting the medication. 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

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

It's always best to discuss your liver condition with your healthcare provider before starting any new medication. They can provide personalized advice and 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 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

You will receive this medication through a dental route, meaning it is specifically administered in a dental setting. 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 or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is MI Paste Plus used for?

MI Paste Plus aids in the prevention of dental cavities.

What is the recommended dosage for adults and children over 12?

Brush your teeth with normal toothpaste at least twice a day, rinse your mouth, apply a pea-sized portion of MI Paste Plus, coat your teeth, and allow 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?

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

What if I accidentally swallow more than the recommended amount?

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

Is there any information about the use of MI Paste Plus during pregnancy?

The insert does not provide specific information regarding the use of MI Paste Plus during pregnancy.

How should MI Paste Plus 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 Melon. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mipaste Plus Melon.
Details

Drug Information (PDF)

This file contains official product information for Mipaste Plus Melon, 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 or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children over the age of 12 are advised to brush their teeth with their regular toothpaste at least twice daily, or as directed by their dental professional or physician. Following brushing, they should rinse their mouth thoroughly. A pea-sized portion of MI Paste Plus should then be dispensed onto a finger and applied evenly to the upper teeth, ensuring complete coverage. 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 physician for appropriate guidance regarding the use of MI Paste Plus.

The route of administration is oral, specifically through application to the teeth. The method involves brushing the teeth, rinsing the mouth, and subsequently applying MI Paste Plus. This regimen should be followed at least twice a day.

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.

This product is contraindicated in patients with known allergies to milk proteins 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 without delay 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 obtain medical assistance or contact a Poison Control Center immediately. Prompt action is necessary to mitigate any potential risks associated with overdose.

Side Effects

Patients should be aware of the following 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 is contraindicated in patients with known allergies to milk protein or hydroxybenzoates. In the event of an allergic reaction, patients are advised to discontinue use immediately, rinse the mouth with water, and seek medical advice.

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 Melon. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mipaste Plus Melon.
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

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 ingests 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 of the potential risks associated with overdosage and the importance of prompt intervention. Symptoms of overdosage may vary, and monitoring the patient closely is essential.

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for the treatment of overdosage, which may involve symptomatic treatment and monitoring of vital signs.

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 text.

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 packaging that includes 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 ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product 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 Melon, 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 Melon, 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.