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Toms Luminous White Fluoride Clean Mint

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Active ingredient
Sodium Fluoride 0.00243 g/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2015
Label revision date
November 13, 2025
Active ingredient
Sodium Fluoride 0.00243 g/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 2015
Label revision date
November 13, 2025
Manufacturer
Tom's of Maine, Inc.
Registration number
M021
NDC root
51009-218

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

Drug Overview

Tom's of Maine Luminous White is a toothpaste designed to help protect against cavities. It comes in a 4.0 oz (113 g) tube and is part of a brand that emphasizes both oral health and environmental responsibility, as reflected in their tagline: "BEAUTIFUL SMILE. BEAUTIFUL PLANET." This product aims to support your dental hygiene while being mindful of the planet.

Uses

You can use this product to help protect against cavities, which are small holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

Additionally, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for most users.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you're helping a child between 2 and 6 years old, make sure to use only a pea-sized amount of toothpaste and supervise them while they brush and rinse to prevent swallowing any toothpaste.

For children under 2 years old, it's best to consult with a dentist or physician before using any toothpaste. They can provide guidance on the safest options for your little one’s dental care.

What to Avoid

It's important to ensure that this product is kept out of reach of children under 6 years old to prevent any accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical assistance immediately or contact the poison control center at (412) 390-3381.

While there are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this product, always use it as directed to ensure safety.

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 the amount used for brushing, seek medical help immediately or call the poison control center at (412) 390-3381.

Always be cautious and ensure that this product is used safely to prevent any potential harm.

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 a child accidentally swallows more than what is typically used for brushing, seek medical help immediately or call the poison control center at (412) 390-3381.

Always use this product as directed and be cautious about the amount used. If you have any concerns or experience unusual symptoms, stop using the product and contact your doctor for further 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. You can call the poison control center at (412) 390-3381 for guidance.

Signs of an overdose may not always be obvious, so it's best to err on the side of caution. If you suspect an overdose, don’t hesitate to reach out for help. Your safety is the priority, and prompt action can make a difference.

Pregnancy Use

It's important to note that there is no specific information available about the use of Tom's Luminous White Fluoride Clean Mint for individuals who are pregnant. This means that safety concerns, dosage adjustments, or any special precautions during pregnancy have not been addressed in the product's information.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any new products, including dental care items, to ensure they are safe for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

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 the amount used for brushing, seek medical help immediately or call the poison control center at (412) 390-3381.

For children aged 2 years and older, you should help them brush their teeth thoroughly, ideally after each meal or at least twice a day, unless directed otherwise by a dentist or physician. For children between 2 and 6 years old, use only a pea-sized amount of the product and supervise their brushing and rinsing to reduce the risk of swallowing. If your child is under 2 years old, consult a dentist or physician for guidance.

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.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with your doctor 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 or monitoring related to renal impairment (kidney issues). This means that there are no detailed recommendations available 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 plan is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep the tube tightly closed when you're not using it to maintain its integrity. If you open the product and do not use it within a certain time frame, be sure to discard it to avoid any safety issues. Following these simple steps will help you handle the product safely and effectively.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market. If you have any questions about how this medication works or its specific use, be sure to consult your healthcare provider.

FAQ

What is Tom's of Maine Luminous White used for?

Tom's of Maine Luminous White helps protect against cavities.

What is the recommended usage for adults and children over 2 years?

Adults and children 2 years of age and older should brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

How should children aged 2 to 6 use this product?

Children aged 2 to 6 should use only 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 more than the recommended amount?

If more than the recommended amount is accidentally swallowed, get medical help or call the poison control center at (412) 390-3381 right away.

Are there any contraindications for using Tom's of Maine Luminous White?

No contraindications are listed for this product.

Is there any specific information regarding use during pregnancy or nursing?

No specific information regarding use during pregnancy or nursing is provided in the product insert.

How should I store Tom's of Maine Luminous White?

Store the product at room temperature, keep the tube tightly closed when not in use, and discard it after opening if not used within a specified time frame.

What is the size of the Tom's of Maine Luminous White tube?

The product is presented in a 4.0 OZ (113 g) tube.

Packaging Info

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

Packaging configurations for Toms Luminous White Fluoride Clean Mint.
Details

Drug Information (PDF)

This file contains official product information for Toms Luminous White Fluoride Clean 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 protection against cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

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.

For children aged 2 to 6 years, it is recommended to use only a pea-sized amount of the product. Caregivers should supervise the child's brushing and rinsing to minimize the risk of swallowing.

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

Contraindications

Use is contraindicated in children under 6 years of age. Due to the potential risk of accidental ingestion, if more than the recommended amount for brushing is swallowed, seek medical assistance immediately or contact a poison control center at (412) 390-3381.

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 that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a poison control center by dialing (412) 390-3381 for further guidance and management of the situation.

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 for brushing is accidentally swallowed, it is imperative to seek medical assistance immediately or contact a poison control center at (412) 390-3381.

Drug Interactions

There are currently no documented drug interactions associated with 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 Toms Luminous White Fluoride Clean Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Toms Luminous White Fluoride Clean Mint.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance should be sought by contacting a poison control center.

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. For children aged 2 to 6 years, only a pea-sized amount should be used, and adult supervision is necessary during brushing and rinsing to minimize the risk of swallowing. For infants and children under 2 years of age, consultation with a dentist or physician is advised prior to use.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Tom's Luminous White Fluoride Clean Mint cavity protection/whitening during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have 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 to fetal outcomes.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information regarding dosage adjustments, monitoring, or precautions. As such, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be advisable to ensure patient safety and therapeutic efficacy.

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, it is critical to seek immediate medical assistance. If an individual accidentally swallows more than the amount typically used for brushing, healthcare professionals should be contacted without delay. The recommended action is to call the poison control center at (412) 390-3381 for guidance.

Prompt intervention is essential to manage potential symptoms associated with overdosage effectively. Healthcare providers should be prepared to assess the situation and provide appropriate care based on the specific circumstances of the incident.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion.

In the event that more than the recommended amount used for brushing is accidentally swallowed, patients should be instructed to seek medical help immediately or contact the poison control center at (412) 390-3381. It is important for patients to understand the potential risks associated with improper use and to act promptly in case of an emergency.

Storage and Handling

The product is supplied in a tube format, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its efficacy. To ensure optimal preservation, the tube should be kept tightly closed when not in use. Additionally, any unused product should be discarded after opening if it is not utilized within the specified time frame.

Additional Clinical Information

The route of administration for the product is dental. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Toms Luminous White Fluoride Clean 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 Luminous White Fluoride Clean 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

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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.