ADD CONDITION

items per page

Toms Whole Care Mouthwash Fresh Mint

Last content change checked dailysee data sync status

Active ingredient
Sodium Fluoride 1 mg/10 mL
Other brand names
Dosage form
Rinse
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2017
Label revision date
January 18, 2024
Active ingredient
Sodium Fluoride 1 mg/10 mL
Other brand names
Dosage form
Rinse
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2017
Label revision date
January 18, 2024
Manufacturer
Tom's of Maine, Inc.
Registration number
M021
NDC root
51009-837

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

Tom's of Maine Whole Care Anticavity Mouthwash is a natural mouthwash that contains fluoride, designed to help you maintain good oral health. It aids in the prevention of dental cavities and fights existing cavities while also freshening your breath. This mouthwash works by restoring minerals and strengthening your tooth enamel, ensuring a cleaner mouth by reaching between your teeth. Plus, it's alcohol-free, making it a gentle option for your daily oral care routine.

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

To use this mouth rinse effectively, you should follow a simple routine. If you are an adult or a child aged 6 years and older, rinse your mouth twice a day after brushing your teeth with toothpaste. Take 10 milliliters of the rinse and swish it vigorously between your teeth for one minute before spitting it out. Remember, do not swallow the rinse.

After using the mouth rinse, it's important to avoid eating or drinking anything for 30 minutes to allow the rinse to work effectively. If you are supervising a child under 12, make sure to guide them on how to rinse properly to prevent swallowing. For children under 6 years old, it's best to consult a dentist or doctor before using the rinse.

What to Avoid

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

If you accidentally swallow more than what is intended for rinsing, 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 you accidentally swallow more than what is used for rinsing, seek medical help or contact a Poison Control Center immediately.

Please be aware of these warnings to ensure safety while using the product.

Warnings and Precautions

It's important to keep this product out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows more than what is intended for rinsing, seek medical help immediately or contact a Poison Control Center.

Always use this product as directed, and if you have any concerns or experience unusual symptoms, stop using it and call your doctor for advice. Your safety is a priority, so please take these precautions seriously.

Overdose

If you accidentally swallow more of this product than intended for rinsing, 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 reach out for assistance.

Signs of an overdose may not always be obvious, but if you experience any unusual symptoms after swallowing too much, it’s crucial to get help right away. Always prioritize your safety and well-being by being aware of the proper usage and potential risks associated with the product.

Pregnancy Use

There is currently no specific information available about the use of Tom's Whole Care Mouthwash Fresh Mint during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product's guidelines.

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 mouthwash, to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available about the use of Tom's Whole Care Mouthwash Fresh Mint during nursing. This means that the effects on breast milk and your nursing infant are not clearly understood.

As always, it's a good idea to consult with your healthcare provider before using any new products while breastfeeding to ensure 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. If your child accidentally swallows more than what is needed for rinsing, seek medical help or contact a Poison Control Center immediately. For children aged 6 years and older, they can use the product twice a day after brushing their teeth with toothpaste.

If your child is under 12, make sure to teach them good rinsing habits to help prevent swallowing. Always supervise younger children until they are able to use the product safely on their own. For children under 6 years old, it's best to consult a dentist or doctor before use.

Geriatric Use

While there is no specific information about the use of Tom's Whole Care Mouthwash Fresh Mint in older adults, it's always wise to approach any new product with caution. If you or a loved one is considering using this mouthwash, it's a good idea to consult with a healthcare provider, especially if there are existing health concerns or medications involved.

Since the drug insert does not mention any dosage adjustments or safety precautions for elderly patients, you should monitor for any unusual reactions or side effects when starting the mouthwash. Keeping an open line of communication with your healthcare provider can help ensure that you make the best choices for oral care.

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 (issues with liver function).

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 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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. This helps maintain its effectiveness. Once you open the product, remember to discard it after use to prevent any contamination or degradation. Following these simple steps will help you use the product safely and effectively.

Additional Information

You should use this product by applying it to your teeth twice a day after brushing with toothpaste. If you have children under 12, it's important to teach them good rinsing habits to help prevent swallowing the product. Make sure to supervise them until they can use it safely on their own.

FAQ

What is Tom's of Maine Whole Care Anticavity Mouthwash?

It is a natural mouthwash with fluoride that aids in the prevention of dental cavities, fights cavities, freshens breath, restores minerals, and strengthens enamel.

How should I use Tom's of Maine Whole Care Anticavity Mouthwash?

Use it twice a day after brushing your teeth. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit it out. Do not swallow the rinse.

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

Get medical help or contact a Poison Control Center right away.

Is this mouthwash safe for children?

Children under 6 years of age should consult a dentist or doctor. For children under 12, instruct them in good rinsing habits and supervise as necessary.

Are there any contraindications for using this mouthwash?

No specific contraindications are listed for Tom's of Maine Whole Care Anticavity Mouthwash.

How should I store Tom's of Maine Whole Care Anticavity Mouthwash?

Store it at room temperature, protect it from light, and discard it after opening.

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

No specific information regarding safety concerns or precautions during pregnancy or nursing is provided.

What are the key benefits of using this mouthwash?

It helps prevent dental cavities, freshens breath, cleans between teeth, and is alcohol-free.

Packaging Info

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

Packaging configurations for Toms Whole Care Mouthwash Fresh Mint.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Tom's of Maine Natural with Fluoride Whole Care® Anticavity Mouthwash is a certified B® Corporation product. This mouthwash is designed to provide six benefits for healthy teeth, including cavity protection, breath freshening, mineral restoration, enamel strengthening, and cleaning between teeth, all while being alcohol-free. The product is available in a fresh mint flavor and is packaged in a 16 fl oz (473 mL) bottle.

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 6 years and older are instructed to use the rinse twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 milliliters of the rinse between the teeth for a duration of 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes post-rinsing to ensure optimal efficacy.

For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision is recommended until the child demonstrates the ability to use the rinse without assistance.

For children under 6 years of age, consultation with a dentist or physician is advised prior to use.

Contraindications

Use of this product is contraindicated in situations where accidental ingestion occurs. If more than the recommended amount for rinsing is swallowed, immediate medical assistance should be sought or contact with a Poison Control Center is advised. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this product out of the reach of children to prevent accidental ingestion. In the event that more than the recommended amount used for rinsing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Toms Whole Care Mouthwash Fresh Mint.
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 rinsing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, the product is indicated for use twice daily after brushing teeth with toothpaste. It is important to instruct children under 12 years of age in proper rinsing techniques to minimize the risk of swallowing. Supervision is recommended for children until they are capable of using the product without assistance.

For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of Tom's Whole Care Mouthwash Fresh Mint, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when recommending this product to geriatric patients.

Due to the absence of clinical findings or data specific to this population, it is advisable for providers to monitor elderly patients closely for any adverse effects or unexpected reactions when using this mouthwash. Individual patient factors should be considered, and if any concerns arise, alternative oral care options may be warranted.

Pregnancy

There is no specific information regarding the use of Tom's Whole Care Mouthwash Fresh Mint during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks. It is recommended that pregnant patients consult their healthcare provider before using this mouthwash or any other oral care products during pregnancy.

Lactation

There is no specific information regarding the use of Tom's Whole Care Mouthwash Fresh Mint in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 more than the amount intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on 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 provided text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for rinsing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This information is crucial for ensuring patient safety and preventing potential adverse effects associated with misuse.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at room temperature, away from direct light to maintain its efficacy. Once opened, the product must be discarded to ensure safety and effectiveness.

Additional Clinical Information

The product is administered via the dental route, with a recommended frequency of twice daily following tooth brushing. Clinicians should instruct patients, particularly children under 12 years of age, on proper rinsing techniques to minimize swallowing, and supervision is advised until the child is capable of using the product independently.

Drug Information (PDF)

This file contains official product information for Toms Whole Care Mouthwash Fresh 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 Toms Whole Care Mouthwash Fresh 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.