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Freshmint Premium Anticavity

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Active ingredient
Sodium Fluoride 2.43 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2013
Label revision date
December 2, 2025
Active ingredient
Sodium Fluoride 2.43 mg/1 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 2013
Label revision date
December 2, 2025
Manufacturer
New World Imports, Inc
Registration number
M021
NDC root
51824-034

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If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to help prevent dental cavities, which are small holes in your teeth caused by decay. By using this product, you can support your oral health and reduce the risk of developing cavities, making it an important part of your dental care routine.

While specific details about how it works are not provided, its primary purpose is to aid in maintaining healthy teeth and gums. Incorporating this into your daily habits can contribute to a healthier smile.

Uses

You can use this product to help prevent dental cavities. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of tooth decay. Regular use is an effective way to maintain a healthy smile and keep your teeth strong.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly after meals or at least twice a day. If you're using this product, make sure not to swallow it. For children under 6 years old, use only a pea-sized amount of toothpaste and supervise their brushing to help them develop good habits and minimize swallowing.

If you have a child under 2 years old, it's best to consult a dentist or doctor for guidance on dental care. Following these steps will help ensure that you and your family maintain good oral hygiene.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. While there are no listed contraindications or concerns about abuse, misuse, or dependence, you should take care when using it. If you accidentally swallow more than what is needed for brushing, please seek professional help or contact a Poison Control Center immediately. Your safety is a priority, so always use the product as directed.

Side Effects

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

Always use this product as directed to minimize any risks. If you have any concerns about its use, please consult with a healthcare professional.

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 or someone else accidentally swallows more than the amount used for brushing, seek professional help or contact a Poison Control Center right away.

Always use this product as directed and be mindful of the recommended dosage to ensure safety. If you have any concerns or experience unusual symptoms, stop using the product and call your doctor for further guidance.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, it’s important to act quickly. You should seek professional help or contact a Poison Control Center right away.

Signs of an overdose may not be immediately obvious, but it’s always better to be safe. If you have any concerns or experience unusual symptoms, don’t hesitate to reach out for assistance. Remember, your health and safety are the top priority.

Pregnancy Use

When it comes to using FRESHMINT PREMIUM ANTICAVITY sodium fluoride paste during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best oral care practices during this time. Always prioritize your health and the health of your baby by seeking professional advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this product while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

Pediatric Use

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

For children aged 2 years and older, you should help them brush their teeth thoroughly after meals or at least twice a day, following your dentist's advice. Make sure they do not swallow the product. Use only a pea-sized amount to minimize swallowing, and supervise their brushing until they develop good habits. If your child is under 2 years old, please consult a dentist or doctor before use.

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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a loved one is an older adult considering this medication, it’s essential to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 protect it from freezing. It's important to keep the tube tightly closed when not in use to maintain its integrity. Additionally, remember to discard any unused product after the expiration date to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

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 reach of children under 6 years old. If a child accidentally swallows more than the amount used for brushing, you should seek professional help or contact a Poison Control Center right away.

To help children under 6 develop good oral hygiene habits, instruct them to use only a pea-sized amount and supervise their brushing until they can do it properly on their own.

FAQ

What is the purpose of this dental product?

This product aids in the prevention of dental cavities.

How should adults and children 2 years and older use this product?

Brush your teeth thoroughly after meals or at least twice a day, or use as directed by a dentist. Do not swallow.

What should I do if a child under 6 years uses this product?

Instruct them in good brushing and rinsing habits, using a pea-sized amount to minimize swallowing, and supervise their brushing until good habits are established.

What should I do if a child is under 2 years old?

Consult a dentist or doctor before use.

What precautions should I take regarding children?

Keep this product out of reach of children under 6 years of age.

What should I do if I accidentally swallow more than the recommended amount?

Seek professional help or contact a Poison Control Center immediately.

Are there any contraindications for this product?

No contraindications are listed for this product.

Is there any information about using this product during pregnancy or lactation?

There is no specific information regarding use during pregnancy or lactation.

How should I store this product?

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

What should I do with unused product after the expiration date?

Discard any unused product after the expiration date.

Packaging Info

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

Packaging configurations for Freshmint Premium Anticavity.
Details

Drug Information (PDF)

This file contains official product information for Freshmint Premium Anticavity, 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. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use. For children under 6 years of age, caregivers should instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. A pea-sized amount of the product is recommended for this age group, and caregivers should supervise the brushing process until good oral hygiene habits are established.

For children under 2 years of age, it is essential to consult a dentist or doctor before use to ensure safety and appropriateness of the product.

Contraindications

There are no contraindications listed for this product. However, in the event of accidental ingestion of an amount exceeding that used for brushing, it is imperative to seek professional assistance or contact a Poison Control Center immediately.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion and potential harm.

In the event of accidental ingestion of an amount exceeding that which is typically used for brushing, it is crucial to seek professional medical assistance or contact a Poison Control Center immediately. Prompt action is essential to ensure the safety and well-being of the individual involved.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of an amount greater than that used for brushing, it is imperative to seek professional help or contact a Poison Control Center immediately.

This warning highlights the importance of proper usage and supervision to prevent serious adverse reactions in young children.

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 necessary at this time.

Packaging & NDC

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

Packaging configurations for Freshmint Premium Anticavity.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this product. For children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist. Children should be instructed not to swallow the product, and a pea-sized amount should be used to minimize swallowing. Caregivers are advised to supervise children's brushing until proper habits are established.

For children under 2 years of age, consultation with a dentist or doctor is necessary prior to use. In the event of accidental ingestion of more than the amount used for brushing, professional help should be sought immediately, or a Poison Control Center should be contacted.

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.

Pregnancy

There is no information available regarding the use of FRESHMINT PREMIUM ANTICAVITY sodium fluoride paste, dentifrice during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider this lack of data when advising women of childbearing potential and weigh the potential risks versus benefits of using this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted in these patients to ensure safety and therapeutic effectiveness.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If a patient accidentally swallows an amount greater than what is typically used for brushing, it is crucial to seek professional assistance without delay.

Healthcare providers should advise the patient or caregiver to contact a Poison Control Center immediately for guidance on the appropriate steps to take. Prompt intervention is essential to mitigate potential adverse effects associated with overdosage.

Monitoring for symptoms related to overdosage is also recommended, although specific symptoms are not detailed in the provided information. Therefore, vigilance in assessing the patient's condition and any emerging symptoms is advised.

In summary, immediate professional help and contact with a Poison Control Center are the recommended actions in the case of overdosage.

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

No postmarketing experience details are available in the insert.

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. It is important to emphasize the potential risks associated with misuse. Instruct patients that if they accidentally swallow more than the amount recommended for brushing, they should seek professional help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing adverse effects related to accidental ingestion.

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, ensuring that it is protected from freezing conditions. Any unused product should be discarded after the expiration date to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. 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 amount used for brushing, patients should seek professional help or contact a Poison Control Center immediately. It is recommended that caregivers instruct children under 6 in proper brushing and rinsing techniques, emphasizing the use of a pea-sized amount to minimize swallowing, and supervise their brushing until good habits are established.

Drug Information (PDF)

This file contains official product information for Freshmint Premium Anticavity, 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 Freshmint Premium Anticavity, 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

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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.