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Mint Fluoride Tooth

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.11 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 8, 2023
Active ingredient
Sodium Fluoride 0.11 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 8, 2023
Manufacturer
Yangzhou SION Commodity Co. , Ltd
Registration number
M021
NDC root
70766-011

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

This medication is designed to help prevent cavities, which are small holes in your teeth caused by decay. By using this drug, you can take an important step towards maintaining your dental health and keeping your smile bright. It's a supportive option for those looking to reduce their risk of developing cavities.

Uses

You can use this product to help prevent cavities, which are small holes in your teeth caused by decay. By incorporating it into your dental care routine, you can support your oral health and reduce the risk of developing these dental issues. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal or at least twice a day. If you're unsure about how often to brush, follow the advice of your dentist or physician. When using toothpaste, remember not to swallow it.

For children under 6 years old, use only a pea-sized amount of toothpaste to help minimize the risk of swallowing. It's also a good idea to supervise young children while they brush their teeth to ensure they do it safely and effectively.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

It's important to keep this product out of the reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center right away. Additionally, do not use the product if the inner foil is torn, cut, or missing, as this could indicate that the product is not safe to use.

Warnings and Precautions

It's important to keep this product out of the reach of children under 6 years old. If a child accidentally swallows more than what is needed for brushing, seek medical help or contact a Poison Control Center right away.

Before using, make sure the inner foil is intact; do not use the product if it is torn, cut, or missing. Always store it safely to prevent accidental ingestion. If you have any concerns or experience unusual reactions, stop using the product and consult your doctor.

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 right away or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not always be obvious, so if you feel unwell after using the product, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

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 safety or use of this medication during pregnancy. This means that there are no established guidelines regarding dosage adjustments or special precautions for pregnant individuals.

Given the lack of information, it's crucial to discuss any medications you are considering with your healthcare provider. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using this product while nursing. Additionally, there is no information available about whether this product is passed into breast milk or any potential risks it may pose to your baby. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of the reach of children under 6 years old. If your child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center right away. To help prevent swallowing, use only a pea-sized amount for children in this age group. Always supervise your child's brushing to ensure they use the product safely and correctly.

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 always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to help manage your care effectively.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and help monitor your liver function as needed.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and avoid freezing it. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you notice that the inner foil is torn, cut, or missing after opening, please discard the product to ensure your safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

This medication is administered through the dental route, meaning it is used in the mouth. It's important to keep this product out of the reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center right away.

Make sure not to use the product if the inner foil is torn, cut, or missing. For children under 6, use only a pea-sized amount to help minimize swallowing, and always supervise their brushing to ensure safety.

FAQ

What is the primary use of this drug?

This drug aids in the prevention of cavities.

How should I use this drug?

Brush your teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

What precautions should I take when using this drug with children?

Supervise children's brushing and use a pea-sized amount to minimize swallowing in children under 6 years.

What should I do if this drug is accidentally swallowed?

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

Are there any contraindications for this drug?

No contraindications are listed in the provided text.

What should I do if the inner foil of the tube is damaged?

Do not use the product if the inner foil is torn, cut, or missing.

How should I store this drug?

Store at room temperature, do not freeze, and keep the tube tightly closed when not in use.

Is there any information regarding the use of this drug during pregnancy or nursing?

No specific information regarding use during pregnancy or nursing mothers is provided.

Are there any known drug interactions with this product?

No specific drug interactions are mentioned.

What should I do if I have concerns about using this drug?

Consult your healthcare provider for any concerns regarding the use of this product.

Packaging Info

Below are the non-prescription pack sizes of Mint Fluoride Tooth (sodium monofluorophosphate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mint Fluoride Tooth.
Details

Drug Information (PDF)

This file contains official product information for Mint Fluoride Tooth, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing cavities, including children and adults. Regular use as part of a comprehensive oral hygiene regimen is recommended to maximize its effectiveness in cavity prevention.

Dosage and Administration

Healthcare professionals are advised to instruct patients to brush their teeth thoroughly, preferably after each meal or at least twice daily, unless otherwise directed by a dentist or physician. It is important to emphasize that the product should not be swallowed.

For children under the age of 6 years, a pea-sized amount of the product should be used to minimize the risk of wallowing. Additionally, it is essential to supervise children's brushing to ensure proper technique and safety during use.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event of accidental ingestion of an amount greater than that typically used for brushing, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

The integrity of the product packaging is crucial for safe use. Therefore, it should not be utilized if the inner foil is torn, cut, or missing, as this may compromise the product's safety and efficacy.

Additionally, it is essential to maintain vigilance regarding the accessibility of this product to children, reinforcing the need for secure storage to prevent accidental ingestion.

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 the reach of children under 6 years of age. In the event that the product is accidentally swallowed in amounts greater than what is typically used for brushing, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Additionally, the product should not be used if the inner foil is torn, cut, or missing, as this may compromise its safety and efficacy.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Mint Fluoride Tooth (sodium monofluorophosphate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mint Fluoride Tooth.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. In the event of accidental ingestion exceeding the amount used for brushing, immediate medical assistance or contact with a Poison Control Center is advised. For children in this age group, it is recommended to use a pea-sized amount of the product to minimize swallowing. Additionally, supervision during brushing is essential to ensure safe 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 no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to 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 patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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, it is crucial for healthcare professionals to act promptly. If a patient accidentally swallows more than the recommended amount used for brushing, immediate medical assistance should be sought. It is advisable to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Healthcare providers should be aware that symptoms of overdosage may vary, and monitoring the patient closely for any adverse effects is essential. The management of overdosage will depend on the specific circumstances and the amount ingested. Therefore, timely communication with poison control and adherence to established protocols for overdosage management are recommended to mitigate potential risks to the patient.

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 these contexts.

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 reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to avoid freezing the product to maintain its integrity. When not in use, the tube should be kept tightly closed to prevent contamination and degradation. Additionally, if the inner foil is torn, cut, or missing after opening, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of the reach of children under 6 years of age. In the event of accidental ingestion of more than the amount used for brushing, medical assistance or contact with a Poison Control Center is recommended. It is important to ensure that the inner foil is intact before use. For children under 6 years, a pea-sized amount should be used to minimize swallowing, and adult supervision during brushing is essential.

Drug Information (PDF)

This file contains official product information for Mint Fluoride Tooth, 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 Mint Fluoride Tooth, 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.