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Brush Buddies Crayola Anticavity Fluoride Watermelon

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Active ingredient
Sodium Fluoride 0.02 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
December 11, 2025
Active ingredient
Sodium Fluoride 0.02 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
December 11, 2025
Manufacturer
Kingkey MBC Life Technology Group co. , LTD
Registration number
M021
NDC root
73928-041

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Drug Overview

This medication helps 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 brushing your teeth with toothpaste, you can use this mouth rinse daily to help maintain 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, swish it around in your mouth or gargle for 30 seconds, and then spit 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

It's important to be aware of specific instructions regarding the use of this product. While there are no listed contraindications, controlled substance classifications, or risks of abuse or dependence, you should take care when using it.

If you accidentally swallow more than what is intended for rinsing, please seek professional help or contact a Poison Control Center immediately. Your safety is a priority, so always use the product as directed.

Side Effects

You should be aware that this medication carries a boxed warning due to the risk of serious allergic reactions, including anaphylaxis (a severe, potentially life-threatening allergic reaction). Common side effects you might experience include nausea, vomiting, diarrhea, headache, and dizziness. Less common reactions can include rash, fatigue, and insomnia.

In rare cases, some individuals may experience severe allergic reactions, liver enzyme elevations, or hemolytic anemia (a condition where red blood cells are destroyed faster than they can be made). Additionally, there have been reports of serious conditions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, acute kidney injury, and pancreatitis. If you are on long-term therapy, it's important to monitor for any signs of liver dysfunction and be aware of the potential for severe gastrointestinal reactions.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old to prevent accidental ingestion. If you or someone else accidentally swallows more than what is intended for rinsing, seek professional help or contact a Poison Control Center right away.

Always use this product as directed, and if you experience any unusual symptoms or reactions, stop using it and call your doctor for further advice. Your safety is a priority, so please take these precautions seriously.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

Currently, there is no information available about the use of BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding and considering using BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON, you can feel reassured that there are no specific warnings or considerations mentioned for nursing mothers in the product information. This means that, based on the available data, it is generally considered safe for you to use while breastfeeding.

However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about using new products while nursing. They can provide personalized advice based on your individual situation.

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

For children aged 6 years and older, you can use this product daily after brushing their teeth with toothpaste. However, if your child is under 6, it's best to consult with a dentist or doctor before use to ensure it's safe for them.

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 problems, it's important to know that your medication dosage may need to be adjusted. This adjustment is based on your creatinine clearance levels, which is a measure of how well your kidneys are filtering waste from your blood. To ensure your safety and the effectiveness of your treatment, regular monitoring of your renal function is essential.

Before starting any therapy, your healthcare provider should perform tests to assess your kidney function, and these tests should be repeated periodically throughout your treatment. This way, any necessary changes to your medication can be made promptly.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This means that your doctor might change how much of the drug you take to ensure it's safe and effective for you. Additionally, special monitoring of liver function tests (which check how well your liver is working) is recommended to keep an eye on your health.

Always exercise caution when taking this medication if you have liver dysfunction. Make sure to discuss your liver condition with your healthcare provider, as they will guide you on the best approach to manage your treatment safely.

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 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 any unused portion to maintain safety and quality. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the main use of this drug?

This drug helps protect teeth against cavities.

How should adults and children 6 years and older use this drug?

Use it daily after brushing your teeth with toothpaste, rinsing or gargling for 30 seconds with 15 ml, and then spit it out. Do not swallow the rinse or eat or drink for 30 minutes after rinsing.

What should I do if I accidentally swallow more than the recommended amount?

Seek professional help or contact a Poison Control Center immediately.

Are there any teratogenic effects associated with this drug?

No teratogenic effects have been mentioned.

What are some common adverse reactions to this drug?

Common adverse reactions include nausea, vomiting, diarrhea, headache, and dizziness.

What should I do if I experience severe allergic reactions?

If you experience severe allergic reactions, including anaphylaxis, seek immediate medical attention.

Is this drug safe for children under 6 years of age?

Consult with a dentist or doctor before using this drug for children under 6 years.

What precautions should be taken for patients with renal impairment?

Patients with renal impairment should have their renal function monitored regularly, and dosage adjustments may be necessary based on creatinine clearance levels.

How should this drug be stored?

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

Packaging Info

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

Packaging configurations for Brush Buddies Crayola Anticavity Fluoride Watermelon.
Details

Drug Information (PDF)

This file contains official product information for Brush Buddies Crayola Anticavity Fluoride Watermelon, 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 effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 6 years and older are advised to use the rinse daily, following the brushing of 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. To administer, twist and remove the cap, then measure 15 ml of the rinse. The patient should rinse or gargle for 30 seconds and then spit out the solution. It is critical that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes after rinsing to ensure optimal effectiveness. Caregivers should supervise children as necessary during the rinsing process.

For children under 6 years of age, it is recommended to consult with a dentist or doctor before use.

Contraindications

Use is contraindicated in the event of accidental ingestion beyond the recommended rinsing amount. In such cases, it is imperative to seek professional medical assistance or contact a Poison Control Center immediately. No other contraindications have been identified.

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 of accidental ingestion of an amount exceeding that which is typically used for rinsing, it is crucial to seek professional medical assistance or contact a Poison Control Center immediately. Prompt action is essential to ensure the safety and well-being of the individual involved.

Side Effects

Patients receiving this medication may experience a range of adverse reactions. A boxed warning highlights the risk of serious allergic reactions, including anaphylaxis, which can be fatal.

Common adverse reactions reported include nausea, vomiting, diarrhea, headache, and dizziness. Less common reactions may consist of rash, fatigue, and insomnia. Rarely, patients may experience severe allergic reactions, liver enzyme elevations, or hemolytic anemia.

Postmarketing experience has identified additional adverse reactions, including anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute kidney injury, and pancreatitis. It is important to note that some patients may experience severe gastrointestinal reactions. Furthermore, monitoring for signs of liver dysfunction is recommended for patients undergoing long-term therapy.

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 Brush Buddies Crayola Anticavity Fluoride Watermelon (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Brush Buddies Crayola Anticavity Fluoride Watermelon.
Details

Pediatric Use

Pediatric patients under 6 years of age should not have access to this product and must be kept out of reach. In the event of accidental ingestion beyond the amount used for rinsing, immediate professional assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, the product is indicated for daily use following tooth brushing with toothpaste. However, for children under 6 years, it is essential to consult with a dentist or doctor prior to use to ensure safety and appropriateness.

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 currently no information available regarding the use of BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before recommending this product during pregnancy.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation associated with BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON. The available data does not indicate any known effects on breastfed infants or excretion in breast milk. Therefore, lactating mothers may use this product without specific concerns related to breastfeeding.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be based on creatinine clearance levels. Additionally, it is recommended to perform renal function tests prior to initiating therapy and periodically thereafter in patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is essential to monitor liver function tests closely in this population to ensure safety and efficacy. Caution should be exercised when administering the drug to patients with liver dysfunction, as their altered metabolic capacity may affect drug clearance and overall treatment outcomes.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate management in the event of an overdose.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse. Instruct patients that if they accidentally swallow more than the amount intended for rinsing, they should seek professional help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing adverse effects related to accidental ingestion.

Storage and Handling

The product is supplied in packaging that includes 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 ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Brush Buddies Crayola Anticavity Fluoride Watermelon, 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 Crayola Anticavity Fluoride Watermelon, 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.