ADD CONDITION

items per page

Brush Buddies Crayola Anticavity Fluoride Watermelon

Last content change checked dailysee data sync status

Active ingredient
Sodium Fluoride 0.05 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 0.05 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
73928-036

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 protect your teeth against cavities. It works by providing a protective barrier that helps to prevent tooth decay, making it an important part of maintaining good oral health. By using this product, you can take proactive steps to keep your teeth strong and healthy.

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, swish it around in your mouth or gargle for 30 seconds, and then spit it out. Remember, do not swallow the rinse, and avoid eating or drinking anything for 30 minutes after using it to allow the rinse to work effectively.

If you are supervising children aged 6 years and older, ensure they follow these steps correctly. For children under 6 years old, it’s important to consult with a dentist or doctor before using the rinse.

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 you or someone else accidentally swallows more than what is needed for rinsing, seek professional help or contact a Poison Control Center right away.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always follow the usage instructions carefully to ensure your safety.

Side Effects

There are no specific side effects associated with the medication mentioned. If you have any concerns or experience unusual symptoms while taking this medication, it's important to consult your healthcare provider for guidance.

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 the amount used for rinsing, seek professional help or contact a Poison Control Center immediately.

There are no specific general precautions or laboratory tests required for safe use mentioned. Always prioritize safety and be aware of how to handle any accidental exposure.

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, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to minimize the risk of an overdose. 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 available information 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 addressed in the product's guidelines.

If you are pregnant or planning to become pregnant, it's 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, 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 safely use this product daily after brushing their teeth with toothpaste. Always ensure that your child understands how to use it properly to promote good dental health.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with your doctor 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. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, you may require a lower dose of your medication.

For those with severe renal impairment, extra caution is necessary to prevent potential toxicity. Always discuss your kidney health with your healthcare provider to ensure you receive the appropriate care and adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that your medication dosage may need to be adjusted. This is because your liver plays a key role in processing many medications, and any impairment can affect how your body metabolizes (breaks down) these drugs. For those with severe liver impairment, a reduced dose may be necessary to ensure safety and effectiveness.

Additionally, your healthcare provider will likely recommend special monitoring of your liver function tests. These tests help track how well your liver is working and can guide any necessary changes to your treatment. Always communicate openly with your doctor about your liver health, as caution is advised when prescribing medications to individuals with liver dysfunction.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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. It's important to keep it out of reach of children under 6 years old. If a child accidentally swallows more than what is used for rinsing, seek professional help or contact a Poison Control Center right away. Always supervise young children when they are using this product, and consult with a dentist or doctor if the child is under 6 years of age.

FAQ

What is the primary use of this product?

This product helps protect teeth against cavities.

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

Use daily after brushing your teeth with toothpaste. Rinse or gargle for 30 seconds with 15 ml and spit out, but do not swallow the rinse.

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

Consult with a dentist or doctor before use, and keep the product out of reach of children under 6.

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 product?

No teratogenic effects are mentioned.

What storage conditions are recommended for this product?

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

Are there any special considerations for patients with renal or hepatic impairment?

Dosage adjustments may be necessary for patients with reduced renal or liver function, and special monitoring is recommended.

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.

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 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. 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 important to instruct patients not to swallow the rinse. Additionally, they should refrain from eating or drinking for 30 minutes following the rinsing procedure. Caregivers should supervise children as necessary during this 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 children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing beyond the recommended use for rinsing, it is imperative to seek professional medical assistance or contact a Poison Control Center immediately.

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 of accidental swallowing of an amount greater than what is typically used for rinsing, it is crucial to seek professional medical assistance or contact a Poison Control Center immediately.

Currently, there are no specific general precautions or laboratory tests required for the safe use of this product. Additionally, there are no outlined instructions for obtaining emergency medical help or directives to stop taking the product and consult a physician. Healthcare professionals should remain vigilant and ensure that patients are informed of these critical safety measures.

Side Effects

No adverse reactions have been reported in the supplied text. As such, there are no documented side effects or safety concerns associated with the use of the product.

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 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 be kept out of reach of this product. For children in this age group, it is recommended to consult with a dentist or doctor prior to use. For children aged 6 years and older, the product is intended for daily use following tooth brushing with toothpaste.

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 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

Dosage adjustments may be necessary for patients with reduced renal function. Regular monitoring of renal function tests is recommended for patients with known kidney problems. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose may be required. Special consideration should be given to patients with severe renal impairment to avoid potential toxicity.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered drug metabolism. Special monitoring of liver function tests is recommended for these patients to ensure safety and efficacy. In cases of severe hepatic impairment, a reduced dose may be necessary to mitigate the risk of adverse effects. Caution is advised when prescribing to patients with liver dysfunction, as their compromised liver function may lead to significant alterations in hepatic metabolism.

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, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this 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.

In the event that a patient accidentally swallows more than the amount intended for rinsing, healthcare providers should instruct them to seek professional help or contact a Poison Control Center immediately. This guidance is crucial to ensure the safety and well-being of the patient.

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

The medication 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 amount used for rinsing, patients should seek professional help or contact a Poison Control Center immediately. Additionally, supervision of children may be necessary, and consultation with a dentist or doctor is recommended for children under 6 years of age.

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.

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.