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Autobrush Mint

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Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Gel
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
February 3, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Gel
Route
Oral
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 2026
Label revision date
February 3, 2026
Manufacturer
Lander Enterprises, LLC
Registration number
M021
NDC root
82913-006
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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, making it an important part of maintaining good oral health. By using this product, you can take proactive steps to keep your smile healthy and reduce the risk of cavities forming.

Uses

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

Dosage and Administration

When using toothpaste, you should apply a pea-sized amount for adults and children aged 2 years and older. If you're using an autobrush, make sure to split that pea-sized amount evenly across both sides of the brush head. For effective cleaning, brush your teeth for 30 seconds using a side-to-side or figure-8 motion. If you're using a manual or electric toothbrush, aim to brush thoroughly for a full 2 minutes.

For children under 6 years old, it's important to supervise their brushing. This helps them learn good brushing habits and reduces the risk of swallowing toothpaste. If your child is under 2 years old, it's best to consult a dentist or physician before using toothpaste.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance) or any explicit instructions advising against its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

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 typically used for brushing their teeth, seek medical help or contact a Poison Control Center immediately.

Always be aware of how to use this product safely to avoid any potential risks.

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 what is typically used for brushing their teeth, you should seek medical help immediately or contact Poison Control for assistance.

Always use this product as directed and be aware of any unusual reactions. If you experience any concerning symptoms or side effects, stop using the product and call your doctor for guidance. 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 may not be obvious, but if you experience any unusual symptoms, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

There is currently no information available about the use of AUTOBRUSH MINT - sodium fluoride gel during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby.

Lactation Use

Currently, there is no specific information available about the use of AUTOBRUSH MINT - sodium fluoride gel for nursing mothers or during lactation (the period when a mother breastfeeds her baby). This means that the effects of this product on breast milk or nursing infants have not been studied or documented.

If you are breastfeeding and considering using this product, it may be a good idea to consult with your healthcare provider to discuss any potential concerns or alternatives. Your health and the health of your baby are important, so getting personalized advice is always a wise choice.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child accidentally swallows more than what is typically used for brushing, seek medical help or contact Poison Control immediately. For children aged 2 years and older, you should apply a pea-sized amount of toothpaste.

When it comes to children under 6, it's essential to supervise their brushing to help them learn good habits and reduce the chance of swallowing toothpaste. If your child is under 2 years old, please consult with a dentist or physician before use to ensure their safety.

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 considering this medication, it’s important to consult with a 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 discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

You should take this medication orally. It's important to keep it out of reach of children under 6 years old. If a child accidentally swallows more than what is used for brushing, seek medical help or contact Poison Control immediately. For children under 6, supervise their brushing to help them develop good habits and reduce the risk of swallowing the medication. Additionally, consult a dentist or physician if the patient is under 2 years old.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of dental cavities.

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

Apply a pea-sized amount of toothpaste and brush for 2 minutes using a manual or electric toothbrush, or for 30 seconds with an autobrush.

What should I do if my child is under 6 years old?

Supervise their brushing to teach good habits and minimize swallowing.

What should I do for children under 2 years old?

Consult a dentist or physician before use.

Are there any warnings I should be aware of?

Keep the product out of reach of children under 6 years of age. If more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center immediately.

How should I store this toothpaste?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Packaging Info

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

Packaging configurations for Autobrush Mint.
Details

Drug Information (PDF)

This file contains official product information for Autobrush Mint, 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

For adults and children aged 2 years and older, a pea-sized amount of toothpaste should be applied. When utilizing an autobrush, this amount should be evenly divided across both sides of the brush head. Brushing should be performed for 30 seconds using either a side-to-side or figure-8 motion. In the case of a manual or electric toothbrush, thorough brushing should be conducted for a duration of 2 minutes.

For children under the age of 6, it is essential to supervise the brushing process to instill proper brushing habits and to minimize the risk of swallowing the toothpaste.

For children under 2 years of age, it is recommended to consult a dentist or physician prior to use.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event that more than the recommended amount 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 young children who may be at risk of adverse effects from improper use.

Side Effects

Patients should be advised to keep this product out of reach of children under 6 years of age. 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 is crucial to ensure the safety and well-being of young children who may inadvertently ingest the product.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 Autobrush Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Autobrush Mint.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. 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, a pea-sized amount of toothpaste should be applied during brushing. It is important that children under 6 are supervised while brushing to promote proper brushing techniques and to minimize the risk of swallowing the toothpaste. 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 is no information available regarding the use of AUTOBRUSH MINT - sodium fluoride gel during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and discuss potential risks and benefits with their patients.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for AUTOBRUSH MINT - sodium fluoride gel. Therefore, the effects on lactating mothers and breastfed infants remain undefined. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

There is no specific information available 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 these patients to ensure safety and efficacy.

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 critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information available when contacting medical professionals or poison control for guidance.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is necessary. It is also recommended that parents supervise brushing to instill good habits and reduce the risk of swallowing for children under 6. For children under 2 years of age, consultation with a dentist or physician is advised.

Drug Information (PDF)

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