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Brush Buddies Barbie Anticavity Fluoride Bubblegum

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Active ingredient
Sodium Fluoride 0.03 g/100 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
October 9, 2025
Active ingredient
Sodium Fluoride 0.03 g/100 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
October 9, 2025
Manufacturer
Kingkey MBC Life Technology Group co. , LTD.
Registration number
M021
NDC root
73928-020

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Drug Overview

This medication is designed to help protect your teeth against cavities, which are small holes that can form in your teeth due to decay. By using this product, you can support your dental health and reduce the risk of developing cavities, contributing to a healthier smile.

Uses

You can use this product to help protect your teeth against cavities. It works by strengthening your tooth enamel, making it more resistant to decay. This is especially important for maintaining good oral health and preventing dental issues in the future.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for those looking to enhance their dental care routine.

Dosage and Administration

After you brush your teeth with toothpaste, you can use this mouth rinse daily to help maintain your oral health. Before using the rinse, make sure to rinse your mouth to remove any leftover toothpaste. Shake the bottle well, then twist off the cap. Measure out 15 ml (about one tablespoon) of the rinse, and swish it around in your mouth or gargle for 30 seconds before spitting it out. Remember, do not swallow the rinse.

It's important to avoid eating or drinking anything for 30 minutes after using the rinse to allow it to work effectively. If you're supervising children, make sure they follow these instructions carefully. For children under 6 years old, it's best to consult with a dentist or doctor before use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

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 what is used for rinsing, you should seek professional help or contact a Poison Control Center right away.

Always use this product as directed to minimize any risks. If you have any concerns about its use or potential side effects, please consult with a healthcare professional.

Warnings and Precautions

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 needed for rinsing, you should seek professional help or contact a Poison Control Center right away.

Always use this product as directed. If you experience any unusual symptoms or reactions, stop using it and call your doctor for advice. Your safety is a priority, so don’t hesitate to reach out for help if you have any concerns.

Overdose

If you accidentally swallow more of the medication than intended for rinsing, it’s important to act quickly. You should seek professional help or contact a Poison Control Center right away.

Signs of an overdose can vary, but it’s crucial to be aware of any unusual symptoms you may experience. If you notice anything concerning, don’t hesitate to reach out for assistance. Remember, it’s always better to be safe and get help if you think you may have taken too much.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware 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 consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child is under 6, you should consult with a dentist or doctor before use. For children aged 6 and older, you can help them use the product safely. They should use it daily after brushing their teeth with toothpaste, making sure to rinse out the toothpaste first. The recommended amount is 15 ml, which they should rinse or gargle for 30 seconds before spitting it out. Remind them not to swallow the rinse and to avoid eating or drinking for 30 minutes after using it. Always supervise younger children during this process to ensure their safety.

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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines provided regarding dosage adjustments, special monitoring, or safety considerations for your condition. This means that the information available does not outline any changes you may need to make to your treatment or any additional precautions you should take.

Always consult with your healthcare provider for personalized advice and to ensure your treatment is safe and effective, especially if you have renal impairment (kidney problems). They can help you understand how your condition may affect your medication and what steps to take for your health.

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 should be used 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 determine the best course of action based on your individual situation.

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 everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

You should take this medication orally and be aware of some important safety tips. Keep it out of reach of children under 6 years old. If a child accidentally swallows more than the amount used for rinsing, seek professional help or contact a Poison Control Center right away. Remember, do not swallow the rinse, and avoid eating or drinking for 30 minutes after using it. Supervise children as needed during use to ensure their safety.

FAQ

What is the primary use of this drug?

This drug helps protect teeth against cavities.

Who can use this product?

Adults and children 6 years and older can use it daily after brushing their teeth.

What should I do before using the rinse?

You should rinse the toothpaste from your mouth prior to use.

How should I use the rinse?

Shake well, twist off the cap, rinse or gargle with 15 ml for 30 seconds, and then spit it out. Do not swallow the rinse.

Are there any age restrictions for this product?

Keep out of reach of children under 6 years of age. Consult a dentist or doctor for children under 6.

What precautions should I take after using the rinse?

Do not eat or drink for 30 minutes after rinsing.

What should I do if a child accidentally swallows the rinse?

If a child accidentally swallows more than used for rinsing, seek professional help or contact a Poison Control Center immediately.

How should I store this product?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Is this product safe to use during pregnancy or while nursing?

There are no specific warnings or recommendations regarding use during pregnancy or by nursing mothers.

Packaging Info

Below are the non-prescription pack sizes of Brush Buddies Barbie Anticavity Fluoride Bubblegum (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Brush Buddies Barbie Anticavity Fluoride Bubblegum.
Details

Drug Information (PDF)

This file contains official product information for Brush Buddies Barbie Anticavity Fluoride Bubblegum, 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 drug.

Uses and Indications

This drug is indicated for the protection of teeth against cavities.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 6 years and older are advised to use the rinse daily after brushing their teeth with toothpaste. Prior to use, it is essential to rinse the mouth thoroughly to remove any residual toothpaste. The bottle should be shaken well before each use, and the cap should be twisted and removed.

For administration, the recommended dosage is 15 ml of the rinse. The patient should rinse or gargle for a duration of 30 seconds and then spit out the solution. It is critical to instruct patients not to swallow the rinse. Additionally, patients should refrain from eating or drinking for 30 minutes following the rinsing procedure to ensure optimal effectiveness.

Children under the age of 6 years should be supervised during use, and it is recommended to consult with a dentist or doctor before administering the rinse to this age group.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event of accidental ingestion of an amount exceeding that intended for rinsing, immediate professional assistance should be sought, or the individual should contact a Poison Control Center without delay.

Healthcare professionals are advised to educate caregivers on the importance of proper storage and handling to prevent accidental ingestion. Regular monitoring of the product's usage and ensuring that it is stored securely can mitigate risks associated with unintentional exposure in young children.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of more than the amount used for rinsing, it is imperative to seek professional help or contact a Poison Control Center immediately.

While specific adverse reactions were not detailed in clinical trials or postmarketing experiences, the importance of adhering to safety guidelines cannot be overstated to prevent serious outcomes.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Brush Buddies Barbie Anticavity Fluoride Bubblegum (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Brush Buddies Barbie Anticavity Fluoride Bubblegum.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For this age group, consultation with a dentist or doctor is recommended prior to use.

For children aged 6 years and older, the product is intended for daily use following tooth brushing with toothpaste. It is important to rinse the mouth thoroughly to remove any toothpaste before using the product. The recommended usage involves rinsing or gargling with 15 ml for 30 seconds, after which the solution should be spat out. Swallowing the rinse is contraindicated, and it is advised that patients refrain from eating or drinking for 30 minutes post-rinsing. Supervision of children during use is necessary to ensure safety.

Geriatric Use

There is no specific information available 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 available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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 imperative to seek professional assistance or contact a Poison Control Center immediately if an individual accidentally swallows more than the recommended amount used for rinsing.

Healthcare professionals should be aware that prompt action is crucial in managing potential overdosage situations. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to ensure appropriate interventions are implemented.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

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 light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion beyond the intended use for rinsing, patients should seek professional help or contact a Poison Control Center immediately. It is important to instruct patients not to swallow the rinse and to refrain from eating or drinking for 30 minutes following rinsing. Additionally, supervision of children during use is recommended to ensure safety.

Drug Information (PDF)

This file contains official product information for Brush Buddies Barbie Anticavity Fluoride 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 Brush Buddies Barbie Anticavity Fluoride 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.

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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.