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Simply White

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.0024 g/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2011
Label revision date
February 3, 2011
Active ingredient
Sodium Fluoride 0.0024 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 2011
Label revision date
February 3, 2011
Manufacturer
Tom's of Maine, Inc.
Registration number
part355
NDC root
51009-148

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

Drug Overview

Tom's OF MAINE™ Simply White® is a natural fluoride toothpaste designed to help protect your teeth against cavities while also providing whitening benefits and freshening your breath. This toothpaste has been available since 1970 and is formulated to support your oral health in a gentle, effective way.

By using this toothpaste, you can maintain a brighter smile and enjoy the confidence that comes with fresh breath, all while benefiting from the protective qualities of fluoride.

Uses

You can use this product to help protect your teeth against cavities. Cavities are areas of decay that can develop in your teeth, leading to pain and other dental issues. By using this product, you can take an important step in maintaining your oral health and keeping your smile bright.

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 aged 2 years or older, make sure they brush their teeth properly, and follow any specific advice from their dentist or doctor.

For children between 2 and 6 years old, use only a small amount of toothpaste—about the size of a pea. It's essential to supervise them while they brush and rinse to prevent them from swallowing the toothpaste. If your child is under 2 years old, it's best to consult with a dentist or physician before using any toothpaste.

What to Avoid

It's important to keep this product out of the reach of children under 6 years old to ensure their safety. 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.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. However, always use it as directed to avoid any potential issues.

Side Effects

It's important to keep this product out of the reach of children under 6 years old. 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 to minimize any risks associated with accidental ingestion. Your safety is a priority, so please take these precautions seriously.

Warnings and Precautions

It's important to keep this product out of the reach of children under 6 years old 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

When it comes to using SIMPLY WHITE CLEAN MINT - sodium fluoride paste, dentifrice during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the manufacturer has not provided guidance on how this product may affect you or your developing baby.

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. They can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this product out of the 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.

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, following the guidance of 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 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.

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 circumstances.

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 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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep the tube tightly closed when not in use. It's important to protect it from excessive heat, as high temperatures can affect its quality. Please do not freeze the product, as this can also compromise its effectiveness. If you open the tube and do not use the contents within a specified time frame, be sure to discard it to maintain safety and efficacy.

Additional Information

This medication is administered through dental use. It's important to keep it out of the reach of children under 6 years old. If a child accidentally swallows more than what is used for brushing, seek medical help immediately or call the Poison Control Center at (412) 390-3381. For children aged 2 to 6 years, use only a pea-sized amount and supervise their brushing and rinsing to reduce the risk of swallowing. If you have a child under 2 years old, consult a dentist or physician before use.

FAQ

What is Tom's OF MAINE™ Simply White®?

Tom's OF MAINE™ Simply White® is a natural fluoride toothpaste that helps protect against cavities, whitens teeth, and freshens breath.

Who can use this toothpaste?

Adults and children 2 years of age and older can use this toothpaste. Children 2 to 6 years should use only a pea-sized amount and be supervised while brushing.

What should I do if a child under 2 years needs to use this toothpaste?

If a child is under 2 years old, you should ask a dentist or physician before use.

How should I use Tom's OF MAINE™ Simply White®?

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

Are there any warnings for using this toothpaste?

Yes, keep the toothpaste out of the reach of children under 6 years of age. If more than the amount used for brushing is accidentally swallowed, seek medical help immediately.

How should I store Tom's OF MAINE™ Simply White®?

Store the toothpaste at room temperature, keep the tube tightly closed when not in use, protect it from excessive heat, and do not freeze.

Are there any contraindications for this toothpaste?

No specific contraindications are listed for Tom's OF MAINE™ Simply White®.

Is there any information regarding its use during pregnancy or lactation?

The provided text does not include specific information regarding the use of this toothpaste during pregnancy or lactation.

Packaging Info

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

Packaging configurations for Simply White.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Tom's of Maine™ Simply White® Fluoride Toothpaste is a natural fluoride toothpaste formulated for whitening, cavity protection, and fresh breath. It features a clean mint flavor and is presented in a net weight of 133.2 grams (4.7 ounces). The brand, Tom's of Maine™, has been established since 1970, emphasizing its commitment to natural product offerings.

Uses and Indications

This drug is indicated for the protection against cavities. There are no teratogenic or nonteratogenic effects associated with its use.

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 a day, unless otherwise 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 necessary 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 the 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 used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact the Poison Control Center at (412) 390-3381 for guidance and support in managing the situation effectively.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is crucial to keep the 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, it is imperative to seek medical assistance immediately or contact the Poison Control Center at (412) 390-3381.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond the outlined warnings. However, the importance of adhering to the usage guidelines cannot be overstated to ensure safety and minimize any potential risks.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Simply White.
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 should be sought by contacting the Poison Control Center at (412) 390-3381.

For children aged 2 years and older, it is recommended to brush 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, 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of SIMPLY WHITE CLEAN MINT - sodium fluoride paste, dentifrice 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 warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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 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 typically used for brushing, it is imperative to seek medical help without delay. Healthcare professionals should advise contacting the Poison Control Center at (412) 390-3381 for further guidance.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage any complications that may arise. It is recommended that healthcare professionals remain vigilant and follow established protocols for the evaluation and treatment of overdosage cases.

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 compound in these areas.

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 that must be kept tightly closed when not in use to maintain its integrity. It should be stored at room temperature, away from excessive heat, and must not be frozen. It is important to discard the product after opening if it is not used within the specified time frame.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the 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 swallowed, immediate medical assistance should be sought by contacting the Poison Control Center at (412) 390-3381. For children aged 2 to 6 years, it is recommended to use only a pea-sized amount and to supervise the child's brushing and rinsing to minimize the risk of swallowing. For children under 2 years, consultation with a dentist or physician is advised.

Drug Information (PDF)

This file contains official product information for Simply White, 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 Simply White, 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.

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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.