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Mipaste Plus Strawberry

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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
December 19, 2025
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
December 19, 2025
Manufacturer
GC America Inc.
Registration number
M021
NDC root
61596-986
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 be used during cleaning and polishing procedures as part of a professional dental treatment. It helps in maintaining oral health by providing a protective layer on your teeth.

In addition to its primary use, MI Paste Plus can also assist in managing tooth sensitivity, especially after procedures like scaling, root planing, and bleaching. This makes it a valuable option for those looking to enhance their dental care experience.

Uses

MI Paste Plus is designed to help with cleaning and polishing procedures during professional dental treatments. It plays a key role in maintaining oral health as part of a prophylaxis (preventive) approach.

In addition to its primary use, MI Paste Plus can also assist in managing tooth sensitivity, especially after procedures like scaling, root planing, or bleaching. This makes it a versatile option for enhancing your comfort during and after dental care.

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 advises. 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 it off.

If you have a child under the age of 12, it's best 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 never allow children under 6 years of age to access this medication, as it should be kept out of their reach to prevent any potential harm.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always follow the guidance provided by your healthcare professional and use medications responsibly.

Side Effects

You should be aware that this medication is not suitable for individuals who are allergic to milk proteins or hydroxybenzoates. If you experience an allergic reaction, it’s important to stop using the product immediately, rinse your mouth with water, and seek medical advice. Additionally, if you accidentally swallow more than the amount intended for brushing, please seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

It's important to be aware of certain precautions when using this product. If you have an allergy to milk proteins or hydroxybenzoates, you should not use it. 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 intended for brushing, it's crucial to get medical help or contact a Poison Control Center right away. Additionally, please keep this product out of reach of children under 6 years of age to ensure their safety.

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 include unusual symptoms, but specific details on these symptoms are not provided. If you notice anything concerning after swallowing too much, it’s best to err on the side of caution and get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of MIPASTE PLUS STRAWBERRY during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been established.

Given this lack of information, it is advisable to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your individual health needs. Always prioritize open communication with your doctor regarding any medications or supplements you are considering during pregnancy.

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 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. This will help ensure that it is appropriate for their specific needs and circumstances. Always prioritize your child's health by seeking professional advice when it comes to their care.

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 for personalized advice. 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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function 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. Currently, there are no known interactions between this medication and other drugs or laboratory tests. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account your unique health situation. Always feel free to ask questions and share any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best results with your product, it's important to store it properly. Keep it in a cool, dry place, away from direct sunlight and extreme temperatures. This helps maintain its effectiveness and safety. When handling the product, always follow the application instructions provided in the product insert to ensure you use it correctly and safely.

If you have any questions about how to use the product or need more detailed instructions, refer to the product insert for additional guidance. Proper storage and handling are key to ensuring the product works as intended and remains safe for use.

Additional Information

No further information is available.

FAQ

What is MI Paste Plus used for?

MI Paste Plus is used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. It can also help manage tooth sensitivity, post-scaling, root planing, and bleaching.

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

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

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

Children under the age of 12 should consult their dental professional or doctor before using MI Paste Plus.

Are there any contraindications for using MI Paste Plus?

MI Paste Plus should not be used on patients with a milk protein or hydroxybenzoates allergy.

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

If you experience an allergic reaction, stop using MI Paste Plus, rinse your mouth with water, and seek medical advice.

Is MI Paste Plus safe for nursing mothers?

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

What precautions should I take regarding children and MI Paste Plus?

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

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

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

Packaging Info

Below are the non-prescription pack sizes of Mipaste Plus Strawberry (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mipaste Plus Strawberry.
Details

Drug Information (PDF)

This file contains official product information for Mipaste Plus Strawberry, 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 use in cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. Additionally, MI Paste Plus may be utilized for the management of tooth sensitivity following scaling, root planing, and bleaching procedures.

There are no teratogenic or nonteratogenic effects associated with this drug.

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 physician. Following brushing, the mouth should be rinsed thoroughly. A pea-sized portion of MI Paste Plus should be dispensed onto a finger and applied evenly to coat the upper teeth, followed by a similar application to 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 on the use of MI Paste Plus.

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

Patients with a known allergy to milk proteins or hydroxybenzoates should not use this product. In the event of an allergic reaction, it is imperative to discontinue use immediately, rinse the mouth thoroughly with water, and seek medical advice.

In cases of accidental ingestion exceeding the recommended amount for brushing, it is crucial to obtain medical assistance or contact a Poison Control Center without delay.

This product must be kept out of reach of children under 6 years of age to prevent accidental ingestion and potential harm.

Side Effects

Patients should be aware of the potential for serious allergic reactions associated with the use of this product. It is contraindicated in individuals with known allergies to milk protein or hydroxybenzoates. In the event of an allergic reaction, patients are advised to discontinue use immediately, rinse their mouth with water, and seek medical advice promptly.

Additionally, if a patient accidentally ingests more than the recommended amount for brushing, it is crucial to seek medical assistance or contact a Poison Control Center without delay. These precautions are essential to ensure patient safety and mitigate the risk of adverse effects.

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 Strawberry (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mipaste Plus Strawberry.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this medication due to safety concerns. For children under the age of 12, it is advised to consult a dental professional or doctor prior to use to ensure appropriate guidance and care.

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 no specific information available regarding the use of MIPASTE PLUS STRAWBERRY during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should exercise caution when prescribing this product to women of childbearing potential and consider the lack of data on potential fetal impacts. It is advisable to weigh the benefits against any potential risks when making treatment decisions for pregnant patients.

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 relation to 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 the 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 limits the understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Notable among these are allergic reactions, which include manifestations such as rash, itching, and swelling. Additionally, there have been reports of gastrointestinal disturbances, specifically instances of nausea and vomiting, occurring after the use of the product.

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 available in various package configurations, with specific NDC numbers provided for identification. It is essential to store the product under controlled conditions to maintain its efficacy. The recommended storage temperature range is between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F).

The product should be kept in its original container to protect it from light and moisture. Special handling precautions should be observed to ensure the integrity of the product. For additional application instructions, healthcare professionals are advised to refer to the product insert.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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