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The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast

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Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
October 30, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
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 2025
Label revision date
October 30, 2025
Manufacturer
HISMILE PTY LTD
Registration number
M021
NDC root
83013-344
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, which can be especially important for maintaining good oral health. By using this product, you can take an active step in reducing the risk of cavities and promoting a healthier smile.

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. Keeping your teeth healthy is essential for maintaining a bright smile and overall well-being.

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, make sure to teach them good brushing and rinsing habits to prevent swallowing toothpaste. It's also a good idea to supervise them while they brush until they can do it on their own.

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

What to Avoid

It's important to follow specific guidelines when using this medication to ensure your safety. You should never swallow the medication or use it in the eye area, as these actions can lead to unwanted effects.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication, adhering to the "do not take/use" instructions is crucial for your well-being. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

When using this product, it's important to avoid swallowing it and to keep it away from your eye area. Additionally, make sure to keep it out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

It's important to use this product safely. Do not swallow it or apply it near your eyes. Keep it out of reach of children under 6 years old to prevent accidental ingestion.

If you accidentally swallow more than what is needed for brushing, seek medical help immediately or contact a Poison Control Center. Always prioritize safety and be aware of how to use the product correctly.

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

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should discuss it with your healthcare provider to understand any potential risks and to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. For children in this age group, you should teach them proper brushing and rinsing techniques to help prevent swallowing the product. Always supervise younger children until they can use it safely on their own.

If your child is under 2 years old, it's best to consult with a dentist or doctor before use. For children aged 2 and older, encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, or follow the guidance of a healthcare professional.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about its effects or safety for this age group. This means that if you or a loved one is an older adult, it's especially important to consult with a healthcare provider before starting the medication. They can help assess any potential risks and determine the appropriate dosage based on individual health needs.

Always keep in mind that older adults may have different responses to medications due to factors like age-related changes in the body and existing health conditions. Therefore, regular check-ins with your healthcare provider can ensure that the treatment remains safe and effective.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have kidney issues, it's important to consult your healthcare provider for personalized advice regarding any medications you may be taking. They can help ensure your treatment is safe and effective based on your individual health needs.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include any specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established recommendations for how your liver health might affect the use of this medication.

Always consult with your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver condition. They can help you understand how to manage your health effectively while considering your liver function.

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 your overall treatment plan is safe and effective. Always share your complete list of medications and any health conditions you have, as this information is crucial for your safety and well-being.

Storage and Handling

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

Additional Information

You should apply this topical treatment by brushing your teeth thoroughly, ideally after each meal or at least twice a day, unless your dentist or doctor advises otherwise. If you're supervising children under 6, make sure to guide them in proper brushing and rinsing techniques to help prevent swallowing. For children younger than 2 years old, it's best to consult a dentist or doctor before use.

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 product?

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

What should I do if a child under 6 years uses this product?

Instruct children under 6 in good brushing and rinsing habits to minimize swallowing, and supervise them until they can use it without help.

What should I do if more than the recommended amount 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 this drug?

No contraindications are listed for this drug.

What precautions should I take when using this product?

Do not swallow the product and do not use it in the eye area. Keep it out of reach of children under 6 years.

How should I store this product?

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

Is this product safe for children under 2 years?

Consult a dentist or doctor before using this product for children under 2 years of age.

Packaging Info

Below are the non-prescription pack sizes of The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast.
Details

Drug Information (PDF)

This file contains official product information for The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast, 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

Adults and children aged 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor. It is important to instruct children under 6 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

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

Contraindications

Use of this product is contraindicated in the following situations:

Swallowing the product is prohibited, as it may lead to adverse effects. Additionally, application in the eye area is contraindicated due to the potential for irritation or injury.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings This product is not intended for ingestion; therefore, it must not be swallowed. Additionally, it should not be applied in the eye area to prevent potential irritation or injury.

General Precautions To ensure safety, this product should be kept out of the reach of children under the age of 6 years.

Emergency Medical Assistance In the event that more than the recommended amount for brushing is accidentally swallowed, it is crucial to seek emergency medical assistance immediately or contact a Poison Control Center for guidance.

Discontinuation of Use If any adverse reactions occur, it is advised to stop using the product and consult a healthcare professional for further evaluation and management.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is imperative that the product is not swallowed and is not used in the eye area. Additionally, the product 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, it is crucial to seek medical assistance or contact a Poison Control Center immediately. These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be at greater risk.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. It is important to instruct children in this age group on proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is recommended until children are capable of using the product without assistance.

For children under 2 years of age, consultation with a dentist or doctor is advised prior to use. For those aged 2 years and older, it is recommended that they brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in this population, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine the safety profile in this population.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available 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, 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 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 adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to provide the patient with information regarding the substance involved and the quantity ingested to facilitate appropriate medical response.

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 avoid swallowing the product and to use it only as directed for brushing. Patients should be informed that if they accidentally swallow more than the recommended amount, they should seek medical assistance or contact a Poison Control Center immediately. Additionally, it is important to instruct patients not to use the product in the eye area to prevent potential irritation or injury.

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 to ensure optimal quality. 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 topically, with specific instructions for different age groups. 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 doctor. For children under 6 years of age, it is important to instruct them in proper brushing and rinsing techniques to minimize swallowing, and supervision is recommended until they can perform these tasks independently. For children under 2 years of age, consultation with a dentist or doctor is necessary before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast, 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 The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity Toothpast, 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.