Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Freshmint Anticavity Fluoride

Last content change checked dailysee data sync status

Active ingredient
Sodium Fluoride 2.2 mg/1 g
Other brand names
Dosage form
Gel, 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 2010
Label revision date
January 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 2.2 mg/1 g
Other brand names
Dosage form
Gel, 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 2010
Label revision date
January 15, 2025
Manufacturer
New World Imports, Inc
Registration number
M021
NDC root
51824-068
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (7 NDCs)
Packaging & NDC Codes (7)

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

Clear Gel Toothpaste is a type of toothpaste designed to help prevent dental cavities. By using this toothpaste regularly, you can support your oral health and maintain a brighter smile. It is formulated to provide effective cleaning and protection for your teeth, making it a valuable addition to your daily dental care routine.

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 developing cavities, which are small holes in your teeth caused by decay. 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 helping a child under 6, use only a pea-sized amount of toothpaste to minimize the chance of swallowing, and make sure to supervise them until they can brush on their own. Remember, you should not swallow the toothpaste.

If you have a child who is under 2 years old, it's best to consult with a dentist or doctor for guidance on how to care for their teeth properly. Following these steps will help ensure good dental hygiene for you and your family.

What to Avoid

It's important to be aware of certain precautions when using this product. While there are no specific contraindications or risks of abuse, misuse, or dependence associated with it, you should take care to use it as directed.

If you accidentally swallow more than what is recommended for brushing, seek medical assistance or contact a Poison Control Center immediately. Your safety is a priority, so always follow the usage instructions carefully.

Side Effects

It's important to keep this product out of reach of children. If a child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately.

Always be aware of the potential risks associated with any medication or product you use, and don't hesitate to reach out for assistance if needed. Your safety is a priority.

Warnings and Precautions

It's important to keep this product out of reach of children. If a child accidentally swallows more than what is typically used for brushing their teeth, you should seek medical help or contact a Poison Control Center immediately.

Always use this product as directed to avoid any potential issues. If you have any concerns or experience unusual symptoms, stop using the product and call your doctor for advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose can vary, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

When it comes to using FRESHMINT ANTICAVITY FLUORIDE (sodium fluoride gel, dentifrice) during pregnancy, there are no specific guidelines or safety concerns mentioned in the product information. This means that the insert does not provide details on dosage adjustments or special precautions for pregnant individuals.

If you are pregnant or planning to become pregnant, it's always a good idea to consult with your healthcare provider before using any new products, including dental care items like fluoride gel. They can offer personalized advice based on your health needs and circumstances.

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. This means that, according to the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

Additionally, there are no indications that this product is excreted in breast milk, which further supports its use during lactation. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children. If your child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately. For children aged 2 years and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the guidance of a dentist or physician.

For children under 6 years, teach them proper brushing and rinsing techniques, using only a pea-sized amount of toothpaste to reduce the risk of swallowing. Always supervise younger children while brushing until they can do it independently. If your child is under 2 years old, consult a dentist or doctor before use.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective, especially if you have any concerns about 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 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 the 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 safety and effectiveness of your product, it's important to store it properly. Keep the product at room temperature and avoid freezing it, as extreme temperatures can affect its performance. Always keep it out of reach of children to prevent any accidental ingestion or misuse.

Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these guidelines will help you use the product safely and effectively.

Additional Information

This medication is administered through dental use. It's important to keep it out of reach of children. If a child accidentally swallows more than what is used for brushing, seek medical help or contact a Poison Control Center immediately. For children under 6 years old, make sure to teach them proper brushing and rinsing habits, using only a pea-sized amount to minimize swallowing. Always supervise young children until they can brush their teeth without assistance. If your child is under 2 years old, consult a dentist or doctor before use.

FAQ

What is Clear Gel Toothpaste used for?

Clear Gel Toothpaste aids in the prevention of dental cavities.

How should I use Clear Gel Toothpaste?

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

What should I do if a child under 2 years needs to use Clear Gel Toothpaste?

You should ask a dentist or doctor before using it for children under 2 years.

What precautions should I take when using Clear Gel Toothpaste with children?

Instruct children under 6 years in good brushing and rinsing habits, using a pea-sized amount to minimize swallowing, and supervise them until they can use it without help.

What should I do if more than the recommended amount of Clear Gel Toothpaste is swallowed?

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

Are there any contraindications for Clear Gel Toothpaste?

No specific contraindications are listed for Clear Gel Toothpaste.

Is Clear Gel Toothpaste safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of Clear Gel Toothpaste by nursing mothers.

How should I store Clear Gel Toothpaste?

Store Clear Gel Toothpaste at room temperature, keep it out of reach of children, and do not freeze it. Discard after opening.

Packaging Info

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

Packaging configurations for Freshmint Anticavity Fluoride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Clear gel toothpaste is a dental care product formulated to promote oral hygiene. It is presented in a gel dosage form, characterized by its transparent appearance. The formulation is designed to effectively clean teeth, remove plaque, and provide a refreshing taste.

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, preferably after each meal or at least twice daily, or as directed by a dentist or physician. It is important that the product is not swallowed. For children under 6 years of age, caregivers should instruct them in proper brushing and rinsing techniques to minimize swallowing, using only a pea-sized amount of the product. Supervision is recommended for children until they are capable of brushing without assistance.

For children under 2 years of age, it is essential to consult a dentist or physician for appropriate guidance on dental care.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if more than the recommended amount used for brushing is accidentally swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

It is imperative to keep this product out of reach of children. In the event that more than the recommended amount used for brushing is accidentally ingested, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. This precaution is essential to ensure the safety and well-being of pediatric patients.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning underscores the importance of proper usage to prevent potential adverse effects associated with accidental ingestion.

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 Freshmint Anticavity Fluoride (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Freshmint Anticavity Fluoride.
Details

Pediatric Use

Pediatric patients should be instructed to keep the product out of reach of children. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Children under 6 years of age should be guided in proper brushing and rinsing techniques to minimize swallowing, using only a pea-sized amount of the product. Supervision is necessary until children are capable of brushing without assistance.

For children under 2 years of age, consultation with a dentist or physician is recommended 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of FRESHMINT ANTICAVITY FLUORIDE (sodium fluoride gel, dentifrice) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that the potential benefits and risks be evaluated on a case-by-case basis.

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 effects on 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 exceeding that 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.

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 the product out of reach of children to prevent accidental ingestion. It is important to inform patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical assistance or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and addressing any potential risks associated with misuse.

Storage and Handling

The product is supplied in packaging that ensures safety and integrity. It is essential to keep the product out of reach of children to prevent accidental ingestion.

For optimal storage, the product should be maintained at room temperature. It is crucial to avoid freezing, as this may compromise the quality of the product. After opening, the product must be discarded 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. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children under 6 years of age, it is important to instruct them on proper brushing and rinsing techniques, recommending the use of a pea-sized amount to minimize swallowing. Supervision is necessary until children are capable of brushing without assistance. For children under 2 years, consultation with a dentist or doctor is recommended.

Drug Information (PDF)

This file contains official product information for Freshmint Anticavity Fluoride, 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 Anticavity Fluoride, 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.