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Brush Buddies Crayola Anticavity Fluoride Strawberry

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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
73928-042

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Drug Overview

This medication is designed to help protect your teeth against cavities. By strengthening your tooth enamel, it plays a crucial role in maintaining your dental health and preventing decay. Regular use can contribute to a healthier smile and reduce the risk of dental issues in the future.

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) associated with this product, so it is considered safe in that regard.

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. Pour 15 ml (which is about one tablespoon) of the rinse into your mouth and swish or gargle it 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

It's important to ensure that this product is kept out of reach of children under 6 years of age to prevent any accidental ingestion. If you or someone else accidentally swallows more than the amount intended for rinsing, please seek professional help or contact a Poison Control Center right away. Your safety is a priority, so always use this product as directed.

Side Effects

You may experience some side effects while taking this medication. Common reactions include headache, nausea, and fatigue. Less frequently, you might notice dizziness or a rash. In rare cases, serious allergic reactions, including anaphylaxis (a severe, life-threatening allergic response), and liver enzyme elevations can occur.

Additionally, some people have reported other side effects after the medication was on the market. These include cardiovascular issues like palpitations and high blood pressure, neurological symptoms such as seizures and tremors, and skin conditions like erythema multiforme and Stevens-Johnson syndrome (a serious skin reaction). If you experience any severe or concerning symptoms, it's important to contact your healthcare provider.

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 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 always important to be aware of the potential signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital. Providing them with details about the medication and the amount taken can be very helpful. Remember, it's always better to be safe and get professional assistance if you have any concerns about medication use.

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 using 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 have them use the product daily after brushing their teeth with toothpaste. This ensures they are using it safely and effectively.

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 considering this medication, it’s important to consult with a healthcare provider. 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, your renal function should be monitored regularly, starting with tests before you begin treatment and continuing periodically thereafter.

Regular monitoring helps your healthcare provider determine the right dosage for you and make any necessary changes. Always discuss your kidney health with your doctor to ensure that your treatment is safe and effective.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. Special monitoring of liver function tests (which check how well your liver is working) is recommended to ensure your safety while using this drug. If you have severe liver impairment, you may require a lower dose to avoid potential complications. Always exercise caution when taking this medication, and discuss any concerns with your healthcare provider to ensure it’s safe for you.

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 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 does this drug do?

This drug helps protect your teeth against cavities.

How should I use this drug?

Use it daily after brushing your teeth with toothpaste. Rinse or gargle for 30 seconds with 15 ml and spit it out.

Are there any age restrictions for using this drug?

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

What should I do if I accidentally swallow this drug?

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

Are there any serious side effects?

Serious allergic reactions, including anaphylaxis, have been reported. Common side effects include headache, nausea, and fatigue.

What should I do if I have liver or kidney problems?

Patients with renal impairment should have their renal function monitored regularly, and dosage adjustments may be necessary for those with liver problems.

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

There are no specific warnings or recommendations regarding use during pregnancy or lactation.

How should I store this drug?

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 Strawberry (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Brush Buddies Crayola Anticavity Fluoride Strawberry.
Details

Drug Information (PDF)

This file contains official product information for Brush Buddies Crayola Anticavity Fluoride Strawberry, 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 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, 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 that the rinse is not swallowed. Following the use of the rinse, patients should refrain from eating or drinking for at least 30 minutes to ensure optimal effectiveness.

Children under the age of 6 years should only use this product under the supervision of a dentist or doctor. Caregivers are encouraged to supervise children as necessary during the rinsing process to ensure safety and proper use.

Contraindications

Use is contraindicated in children under 6 years of age; the product should be kept out of their reach. In the event of accidental ingestion beyond the recommended use for rinsing, it is imperative to seek professional 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 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

Serious allergic reactions, including anaphylaxis, have been reported in patients receiving this treatment. Common adverse reactions observed in clinical trials include headache, nausea, and fatigue. Less common adverse reactions noted include dizziness and rash.

In rare instances, patients have experienced severe allergic reactions and elevations in liver enzymes.

Postmarketing experience has revealed additional adverse reactions. Cardiovascular events such as palpitations and hypertension have been reported. Neurological adverse reactions include seizures and tremors. Dermatologic reactions have also been noted, including erythema multiforme and Stevens-Johnson syndrome.

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 necessary at this time.

Packaging & NDC

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

Packaging configurations for Brush Buddies Crayola Anticavity Fluoride Strawberry.
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 advised 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 no specific information regarding the use of this medication 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. 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 advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

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 during the use of this product.

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 altered drug metabolism and clearance. 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 administering the drug to patients with liver dysfunction, and healthcare providers should closely monitor these individuals throughout the treatment process.

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 arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or a medical toxicologist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

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 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 maintain 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 Strawberry, 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 Strawberry, 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

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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.