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Mipasteone Kids Blue Raspberry

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Active ingredient
Sodium Fluoride 0.24 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
December 19, 2025
Active ingredient
Sodium Fluoride 0.24 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 2021
Label revision date
December 19, 2025
Manufacturer
GC America Inc.
Registration number
M021
NDC root
61596-100

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

You may be interested to know that this medication is designed to help prevent dental cavities. It works by providing protection for your teeth, contributing to better oral health. While specific details about its mechanism of action are not provided, its primary purpose is to support you in maintaining a cavity-free smile.

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) associated with this product, making it a safe option for most users.

Dosage and Administration

To use MI Paste ONE Kids, start by applying a small amount, about the size of a pea, to your toothbrush. This is suitable for both adults and children who are 2 years old or older. For the best results, brush your teeth for 2 minutes, then spit out the paste (this is called expectorating) and avoid eating or drinking anything for 30 minutes afterward.

You should use this paste twice a day to help maintain your dental health. If your child is under 2 years old, it's important to consult with a dentist or physician before using this product.

What to Avoid

It's important to be aware of certain precautions when using this product. You should not use it if you have an allergy to milk protein or hydroxybenzoates. Additionally, keep this product out of reach of children under 6 years old.

If you accidentally swallow more than the recommended amount while brushing, seek medical help or contact a Poison Control Center immediately. Should you experience any allergic reactions, stop using the product, rinse your mouth with water, and consult a healthcare professional. Your safety is a priority, so please follow these guidelines carefully.

Side Effects

You should be aware of some important safety information regarding this product. If you have an allergy to milk protein 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.

Additionally, if you accidentally swallow more than the recommended amount of the paste while brushing, it's crucial to get medical help or contact a Poison Control Center right away. Always keep this product out of reach of children under 6 years of age to ensure their safety.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than the recommended amount of the paste, seek medical help or contact a Poison Control Center immediately.

You should not use this product if you have an allergy to milk protein or hydroxybenzoates (a type of preservative). If you experience any allergic reactions, stop using the product right away, rinse your mouth with water, and consult a doctor for further advice.

Overdose

If you accidentally swallow more than the recommended amount of the paste, 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 get assistance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided. If you notice anything concerning after taking the paste, it’s best to err on the side of caution and reach out for help. Always prioritize your safety and well-being.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of MI Paste ONE Kids during pregnancy has not been established. There are no adequate studies in pregnant women, so potential risks to your baby cannot be ruled out. Therefore, it is crucial to consult your healthcare provider before using this product.

Currently, there are no specific dosage modifications recommended for pregnant women. Always seek guidance from a healthcare professional to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding and considering using MI Paste ONE Kids, it's important to consult with your healthcare professional first. This is because there is a possibility that the product could be passed into your breast milk, which means you should be cautious about its use while nursing. Additionally, the safety of MI Paste ONE Kids during breastfeeding has not been fully established, so it's best to discuss any concerns with your doctor to ensure the well-being of both you and your baby.

Pediatric Use

When using MI Paste ONE Kids, you can apply a small, pea-sized amount to your toothbrush for children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a dentist or physician before use. Please remember to keep this product out of reach of children younger than 6 years old to ensure their safety.

If your child accidentally swallows more than the recommended amount of paste, seek medical help or contact a Poison Control Center immediately. It's always better to be safe and informed when it comes to your child's health.

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 responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 (issues with liver function).

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 use of your product, store it at room temperature. After each use, remember to securely replace the cap to maintain its integrity. It's also important to keep this product out of reach of children under 6 years of age to ensure their safety. Following these simple steps will help you handle the product safely and effectively.

Additional Information

For adults and children aged 2 years and older, you should apply a small, pea-sized amount of MI Paste ONE Kids to your toothbrush. For the best results, brush for 2 minutes, then spit out the paste and avoid eating or drinking for 30 minutes afterward. It's recommended to use this product twice daily.

Make sure to keep this paste out of reach of children under 6 years old. If a child accidentally swallows more than the recommended amount, seek medical help or contact a Poison Control Center immediately. Do not use this product if you or your child have an allergy to milk protein or hydroxybenzoates. If you experience an allergic reaction, stop using it, rinse your mouth with water, and consult a healthcare professional.

FAQ

What is the primary use of MI Paste ONE Kids?

MI Paste ONE Kids aids in the prevention of dental cavities.

How should I use MI Paste ONE Kids?

For adults and children 2 years of age or older, apply a small, pea-size amount to your toothbrush, brush for 2 minutes, expectorate, and avoid eating or drinking for 30 minutes after brushing. Use twice daily.

Is MI Paste ONE Kids safe for children under 2 years of age?

Consult a dentist or physician before using MI Paste ONE Kids for children under 2 years of age.

Are there any contraindications for using MI Paste ONE Kids?

Do not use MI Paste ONE Kids on patients with a milk protein or hydroxybenzoates allergy.

What should I do if I accidentally swallow too much MI Paste ONE Kids?

If more than the recommended amount is swallowed, get medical help or contact a Poison Control Center immediately.

Is MI Paste ONE Kids safe to use during pregnancy?

The safety of MI Paste ONE Kids during pregnancy has not been established; consult a healthcare provider if pregnant or planning to become pregnant.

Can nursing mothers use MI Paste ONE Kids?

Nursing mothers should consult a healthcare professional before using MI Paste ONE Kids, as there is a potential for excretion in breast milk.

What precautions should I take when using MI Paste ONE Kids?

Keep MI Paste ONE Kids out of reach of children under 6 years of age and stop use if an allergic reaction occurs, rinsing the mouth with water and seeking medical advice.

How should I store MI Paste ONE Kids?

Store MI Paste ONE Kids at room temperature and replace the cap after use.

Packaging Info

Below are the non-prescription pack sizes of Mipasteone Kids Blue Raspberry (mi paste one kids blue raspberry). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mipasteone Kids Blue Raspberry.
Details

Drug Information (PDF)

This file contains official product information for Mipasteone Kids Blue Raspberry, 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

For adults and children aged 2 years and older, a small, pea-sized amount of MI Paste ONE Kids should be applied to the toothbrush. It is recommended to brush for a duration of 2 minutes, followed by expectoration. Patients should avoid eating or drinking for 30 minutes after brushing to maximize the effectiveness of the product.

The application of MI Paste ONE Kids should occur twice daily. For children under 2 years of age, it is advised to consult a dentist or physician prior to use.

Contraindications

Use is contraindicated in patients with a known allergy to milk proteins or hydroxybenzoates.

Additionally, the product should not be used in children under 6 years of age. In the event of accidental ingestion of more than the recommended amount, immediate medical assistance or contact with a Poison Control Center is advised. If an allergic reaction occurs, discontinue use, rinse the mouth with water, and seek medical advice.

Warnings and Precautions

It is imperative to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount of paste is swallowed, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

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

In the occurrence of an allergic reaction, it is essential to discontinue use immediately. Patients should rinse their mouths thoroughly with water and seek medical advice to address any adverse effects. Monitoring for signs of allergic reactions is advised to ensure patient safety.

Side Effects

Patients may experience allergic reactions to the product, particularly those with a known allergy to milk protein or hydroxybenzoates. In the event of an allergic reaction, it is advised to discontinue use immediately, rinse the mouth with water, and seek medical advice.

Accidental ingestion of the product, especially if more than the recommended amount of paste is used for brushing, may necessitate immediate medical assistance or contact with a Poison Control Center.

Additionally, it is important to keep the product out of reach of children under 6 years of age to prevent any potential adverse effects associated with inappropriate use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Mipasteone Kids Blue Raspberry (mi paste one kids blue raspberry). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mipasteone Kids Blue Raspberry.
Details

Pediatric Use

For pediatric patients aged 2 years and older, a small, pea-size amount of MI Paste ONE Kids should be applied to the toothbrush for use. In children under 2 years of age, it is advised to consult a dentist or physician prior to use.

Caution is warranted as MI Paste ONE Kids should be kept out of reach of children under 6 years of age. In the event that more than the recommended amount of paste is accidentally swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

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, given the lack of targeted data for this population.

Pregnancy

The safety of MI Paste ONE Kids during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There are no adequate and well-controlled studies in pregnant women, and potential risks to the fetus cannot be ruled out. No specific dosage modifications for pregnant women are provided; therefore, it is advisable for healthcare professionals to offer guidance tailored to individual circumstances.

Lactation

Nursing mothers should consult a healthcare professional before using MI Paste ONE Kids. There is a potential for excretion in breast milk; therefore, caution is advised when administering this product to lactating mothers. The safety of MI Paste ONE Kids during lactation has not been established.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 more than the recommended amount of the paste, 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 the patient for any symptoms that may arise is essential, although specific symptoms related to overdosage are not detailed in the available data.

Management of overdosage should focus on supportive care and symptomatic treatment as necessary. It is advisable to follow established protocols for the management of overdose cases, ensuring that the patient receives appropriate evaluation and treatment based on their clinical presentation.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include manifestations such as rash, itching, and swelling.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. Instruct patients that if more than the recommended amount of paste is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is important to inform patients not to use this product if they have a known allergy to milk protein or hydroxybenzoates. In the event of an allergic reaction, patients should be instructed to stop using the product, rinse their mouth with water, and seek medical advice promptly.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy and stability.

After each use, it is crucial to securely replace the cap to prevent contamination and preserve the integrity of the product. Additionally, to ensure safety, the product should be kept out of reach of children under 6 years of age. Proper handling and storage practices are vital for optimal product performance and safety.

Additional Clinical Information

For patients aged 2 years and older, MI Paste ONE Kids should be administered via the dental route. A small, pea-sized amount is to be applied to the toothbrush, with a recommended brushing duration of 2 minutes. Patients are advised to expectorate and refrain from eating or drinking for 30 minutes post-brushing. This application should occur twice daily.

Clinicians should counsel patients to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of more than the recommended amount, immediate medical assistance or contact with a Poison Control Center is necessary. The product is contraindicated in individuals with allergies to milk proteins or hydroxybenzoates. Should an allergic reaction occur, patients should discontinue use, rinse their mouth with water, and seek medical advice.

Drug Information (PDF)

This file contains official product information for Mipasteone Kids Blue Raspberry, 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 Mipasteone Kids Blue Raspberry, 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.

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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.