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Made by Dentist for Kids Chew Toy Bubblegum

Last content change checked dailysee data sync status

Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
February 21, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste
Route
Dental
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 2024
Label revision date
February 21, 2025
Manufacturer
Fulijaya Manufacturing Sdn. Bhd
Registration number
M021
NDC root
62776-006
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 cavities, which are small holes in your teeth caused by decay. By using this product, you can take an important step towards maintaining your dental health and keeping your smile bright. While the specific details about how it works are not provided, its primary purpose is to support your efforts in cavity prevention.

Uses

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

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly, ideally after each meal or at least twice a day. If you're helping a child under 6 years old, make sure to teach them good brushing and rinsing habits to prevent swallowing toothpaste. For these little ones, use only a pea-sized amount of toothpaste and supervise them until they can brush 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. Following these steps will help ensure that you and your family maintain good oral hygiene.

What to Avoid

It's important to ensure that you use this product safely. Keep it out of reach of children under 6 years of age to prevent any accidental ingestion. If a child accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, always use it as directed to ensure your safety and well-being.

Side Effects

If you accidentally swallow more of this product than intended for brushing, it’s important to seek medical help or contact a Poison Control Center immediately. This is a serious situation that requires prompt attention to ensure your safety. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years of age. If a child accidentally swallows more than what is typically used for brushing, you should seek medical help immediately or contact a Poison Control Center.

While there are no specific precautions or lab tests mentioned, always be mindful of how you use this product. If you have any concerns or experience unusual symptoms, it's best to consult your doctor.

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 are considering during pregnancy.

Lactation Use

Currently, there is no specific information available about the use of MADE BY DENTIST FOR KIDS CHEW TOY BUBBLEGUM sodium fluoride paste for nursing mothers or its effects during breastfeeding. This means that if you are breastfeeding, it’s important to consult with your healthcare provider for personalized advice regarding the use of this product. They can help you understand any potential risks or considerations for both you and your nursing infant.

Pediatric Use

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, seek medical help or contact a Poison Control Center immediately. For children aged 2 years and older, you should encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following the guidance of a dentist or doctor.

For children under 6, teach them proper brushing and rinsing techniques to help prevent swallowing toothpaste, and use only a pea-sized amount. Always supervise younger children while brushing until they can do it on their own safely. If your child is under 2 years old, it's best to consult a dentist or doctor 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 change 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health.

Make sure to keep your doctor informed about your liver condition, as they may need to monitor your liver function tests (which check how well your liver is working) more closely while you are on medication. Your health and safety are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

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 this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from freezing conditions. It's important to handle the product carefully and to discard it after opening to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

The medication is administered through a dental route, meaning it is used in dental care settings. If you are caring for children under 6 years old, it's important to teach them proper brushing and rinsing techniques to help prevent swallowing the product. Use only a pea-sized amount and supervise them until they can use it independently. For children under 2 years of age, consult a dentist or doctor before use.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of cavities.

Who can use this drug?

Adults and children 2 years of age and older can use this drug. Children under 2 years should consult a dentist or doctor.

How should I use this drug?

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

What precautions should I take for children under 6 years of age?

Instruct children under 6 in good brushing and rinsing habits to minimize swallowing, and only use a pea-sized amount. Supervise them until they can use it without assistance.

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.

How should I store this drug?

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

Are there any contraindications for this drug?

No specific contraindications are listed for this drug.

Is there any information regarding use during pregnancy or nursing?

No specific information regarding use during pregnancy or nursing is provided.

What should I do if I have questions about using this drug?

Consult your dentist or doctor if you have any questions or concerns about using this drug.

Packaging Info

Below are the non-prescription pack sizes of Made by Dentist for Kids Chew Toy Bubblegum (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Made by Dentist for Kids Chew Toy Bubblegum.
Details

Drug Information (PDF)

This file contains official product information for Made by Dentist for Kids Chew Toy Bubblegum, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing cavities, including children and adults. Regular use as part of a comprehensive oral hygiene regimen is recommended to maximize its effectiveness in cavity prevention.

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 physician.

For children under 6 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing toothpaste. A pea-sized amount of toothpaste should be used for this age group. Caregivers should supervise children as necessary until they are capable of brushing their teeth without assistance.

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 risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

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. 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 instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

No specific instructions for discontinuation of use or additional general precautions have been provided. Additionally, there are no laboratory tests recommended for monitoring in relation to the safe use of this product.

Side Effects

Patients should be aware that if 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 highlights the potential seriousness of accidental ingestion and underscores the importance of adhering to the recommended usage guidelines to prevent adverse outcomes.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Made by Dentist for Kids Chew Toy Bubblegum (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Made by Dentist for Kids Chew Toy Bubblegum.
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, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age should be instructed in proper brushing and rinsing techniques to minimize swallowing, using only a pea-sized amount of the product. Supervision is necessary until children are capable of brushing without assistance.

For children under 2 years of age, consultation with a dentist or doctor is recommended 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 this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for MADE BY DENTIST FOR KIDS CHEW TOY BUBBLEGUM sodium fluoride paste. Therefore, healthcare professionals should exercise caution and consider the absence of data when advising lactating mothers. The effects on breastfed infants and the excretion of the drug in breast milk remain undetermined.

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 the use of this medication. Consequently, there are no established 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 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 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 have the product's labeling and any relevant patient information available when contacting medical professionals or poison control for guidance.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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. It is important to emphasize the potential risks associated with misuse.

In the event that more than the recommended amount used for brushing is accidentally swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and prompt response in case of an emergency.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from freezing conditions. Once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct parents or guardians to teach children under 6 years of age proper brushing and rinsing habits to minimize swallowing, recommending the use of only a pea-sized amount. Additionally, supervision is advised for children until they are capable of using the product without assistance. For children under 2 years of age, consultation with a dentist or doctor is recommended.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Made by Dentist for Kids Chew Toy Bubblegum, 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 Made by Dentist for Kids Chew Toy Bubblegum, 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.