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Mint Dentistry

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.2938 g/113 g
Other brand names
Dosage form
Paste
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
May 10, 2022
Active ingredient
Sodium Fluoride 0.2938 g/113 g
Other brand names
Dosage form
Paste
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
May 10, 2022
Manufacturer
Nutrix International, LLC.
Registration number
part355
NDC root
73333-115

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 decay. It works by providing support to your dental health, making it easier for you to maintain a healthy smile. While specific details about its mechanism of action are not provided, its primary purpose is to aid in keeping your teeth strong and free from cavities.

Uses

You can use this product to help prevent dental decay, which is the process that leads to cavities in your teeth. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing issues related to tooth decay. Regular use can be an important step in maintaining a healthy smile.

Dosage and Administration

To use this medication, take a small amount about the size of a pea and apply it directly in your mouth. This is the recommended dosage for effective use. Make sure to follow this guideline closely to ensure you get the best results from the treatment.

What to Avoid

It's important to ensure that any medication you use is kept safe and secure. To protect young children, make sure to keep this medication out of their reach, especially if they are under 6 years old. There are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. Always follow these guidelines to ensure safe use.

Side Effects

Using fluoride toothpaste is generally safe, but there are important precautions to keep in mind. It's crucial to keep the toothpaste out of reach of children under 6 years old. If a child accidentally swallows more than the amount typically used for brushing, seek medical help or contact a Poison Control Center immediately.

While side effects are not commonly reported, it's always best to use the product as directed to minimize any potential risks. If you have any concerns or experience unusual reactions, consult your healthcare provider for guidance.

Warnings and Precautions

It's important to keep fluoride toothpaste out of reach of children under 6 years old. If a child accidentally swallows more toothpaste than what is typically used for brushing, you should seek medical help immediately or contact a Poison Control Center.

Always use fluoride toothpaste as directed to ensure safety and effectiveness. If you have any concerns or experience unusual reactions, stop using the product and consult your doctor for further advice.

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 get assistance.

Signs of an overdose may include unusual symptoms, but it’s best to consult a healthcare professional for guidance. Remember, acting quickly can make a significant difference in your health and safety.

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 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 production and the nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider to discuss any medications you are considering while breastfeeding, ensuring the safety and well-being of both you and your baby.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child is under 6, you should only use a pea-sized amount and closely supervise their brushing and rinsing to help prevent swallowing.

For children under 2 years of age, it's best to consult with a dentist or doctor before use to ensure safety and proper guidance. Always prioritize your child's health and safety when using any product.

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 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 great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep the tube tightly closed when not in use. It's important to protect it from excessive heat, as this can affect its effectiveness. If you open the tube and do not use the contents within the specified time, please discard it to maintain safety and quality. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should use a pea-sized amount of the product orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about using this product, consider discussing them with your healthcare provider.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of dental decay.

How should I use this drug?

Use a pea-sized amount via oral application and brush your teeth thoroughly after each meal or at least twice a day.

What are the instructions for children under 6 years of age?

Children under 6 years should use a pea-sized amount and should be supervised while brushing and rinsing to minimize swallowing.

What should I do if a child under 6 accidentally swallows this drug?

If a child accidentally swallows more than the amount used for brushing, seek medical help or call a Poison Control Center immediately.

Is there any information regarding use during pregnancy or nursing?

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

Are there any contraindications for this drug?

No contraindications are listed for this drug.

How should I store this drug?

Store at room temperature, keep the tube tightly closed when not in use, and protect it from excessive heat.

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

For any questions or concerns, especially regarding use for children under 2 years of age, consult a dentist or doctor.

Packaging Info

Below are the non-prescription pack sizes of Mint Dentistry (charcoal spearmint). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mint Dentistry.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by SPL code 34089-3 and is a sterile, non-pyrogenic, isotonic solution intended for intravenous use only. It contains sodium chloride, sodium bicarbonate, and dextrose, with the pH adjusted to a range of 7.0 to 7.5. The solution is packaged in a clear, colorless glass vial, and the inactive ingredient is water for injection.

Uses and Indications

This drug is indicated for the prevention of dental decay. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Healthcare professionals are advised to administer a pea-sized amount of the medication orally. This dosage should be carefully measured to ensure accuracy. It is recommended that the patient takes the medication at the prescribed frequency as determined by the healthcare provider. Proper administration technique should be followed to maximize efficacy and minimize any potential side effects.

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 fluoride toothpaste out of the reach of children under 6 years of age. Accidental ingestion of amounts greater than what is typically used for brushing can pose serious health risks. In such cases, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals are advised to educate caregivers on the importance of supervising young children during tooth brushing to prevent accidental swallowing. Proper storage and usage instructions should be emphasized to ensure the safety of pediatric patients.

Side Effects

Patients should be aware of the following warnings associated with the use of fluoride toothpaste. It is crucial to keep the product out of reach of children under 6 years old. In the event that a child accidentally swallows more than the amount typically used for brushing, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

This precaution is essential to prevent potential adverse reactions related to excessive fluoride ingestion, which can pose serious health risks.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mint Dentistry (charcoal spearmint). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mint Dentistry.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children under 6 years old. For children under 6 years of age, a pea-sized amount is recommended, and adult supervision is necessary during brushing and rinsing to minimize the risk of swallowing. For children under 2 years of age, it is advised to consult a dentist or doctor prior to 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 adverse effects or changes in therapeutic response, 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 and should be informed of the absence of established safety data in pregnancy.

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 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 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 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 related to the specific substance involved is essential, although specific symptoms were not detailed in the provided information.

Management procedures may include supportive care and symptomatic treatment as necessary, depending on the clinical presentation. It is advisable for healthcare providers to follow established protocols for the management of overdosage cases, ensuring that appropriate measures are taken to safeguard the patient's health.

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 compound in these areas.

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 a tube that must be kept tightly closed when not in use to maintain its integrity. It should be stored at room temperature, away from excessive heat to ensure optimal performance. If the product is not used within a specified time after opening, it should be discarded to prevent any potential degradation.

Additional Clinical Information

Patients should use a pea-sized amount of the product via oral administration. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mint Dentistry, 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 Dentistry, 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.