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Brush Buddies Crayola 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
December 11, 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
December 11, 2025
Manufacturer
Kingkey MBC Life Technology Group co. , LTD.
Registration number
M021
NDC root
73928-017

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

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. 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 use the rinse properly. 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

It's important to be aware of potential adverse reactions when using this medication. You should 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.

While specific side effects are not detailed here, always monitor for any unusual reactions and consult your healthcare provider if you have concerns. Your safety is a priority, so don't hesitate to reach out for guidance if needed.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years of age 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 be mindful of any unusual reactions. If you experience any concerning symptoms, stop using the product and call your doctor for further advice. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

It's important to keep this medication 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.

In case of an overdose, you may notice signs such as unusual drowsiness or difficulty breathing. If you or someone else experiences these symptoms, it's crucial to get medical assistance immediately. Always prioritize safety and act quickly if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking any medication, including this one, you should consult with your healthcare provider to discuss potential risks and benefits, ensuring the best care for you and your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

Currently, there is no specific information available about the use of BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM for nursing mothers or its effects on breastfeeding. This means that if you are breastfeeding, you may want to consult with your healthcare provider for personalized advice regarding the use of this product. It's always best to ensure that any product you use is safe 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 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 oral 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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

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 recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your liver is functioning well while you are on medication. Your safety and well-being 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 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 discuss your full list of medications, including over-the-counter drugs and supplements, as well as any lab tests you may need. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the bottle tightly closed when you're not using it to prevent contamination. If you open the bottle, be sure to discard any unused portion after a specified time frame to maintain safety and effectiveness.

Additional Information

No further information is available.

FAQ

What is the main use of this drug?

This drug helps protect teeth against cavities.

Who can use this drug?

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

What should I do before using the rinse?

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

How do I use this 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 precautions for children?

Children under 6 years of age should be supervised and consult with a dentist or doctor before use.

What should I do if I accidentally swallow the rinse?

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

Are there any contraindications for this drug?

No contraindications are listed for this drug.

How should I store this drug?

Store at room temperature, protect from light, and keep the bottle tightly closed when not in use.

Packaging Info

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

Packaging configurations for Brush Buddies Crayola Anticavity Fluoride Bubblegum.
Details

Drug Information (PDF)

This file contains official product information for Brush Buddies Crayola 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 that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes following the use of the rinse 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

Use is contraindicated in children under 6 years of age due to the potential 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 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 should be aware of the potential adverse reactions 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 intended 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. Proper usage is essential to minimize risks and ensure the safety of all users, particularly vulnerable populations such as young children.

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 warranted at this time.

Packaging & NDC

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

Packaging configurations for Brush Buddies Crayola Anticavity Fluoride Bubblegum.
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 statements or information regarding nursing mothers or lactation in the provided drug insert for BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM. Therefore, the effects on lactating mothers and breastfed infants are not addressed. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 overdosage, it is crucial to keep the product out of reach of children under 6 years of age. Accidental ingestion of amounts exceeding those recommended for rinsing may lead to serious health concerns.

Healthcare professionals are advised to instruct caregivers to seek immediate medical assistance or contact a Poison Control Center if an overdose occurs. Prompt action is essential to mitigate potential risks associated with overdosage.

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 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 minimizing the risk of adverse effects.

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to protect the product from light exposure to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, it is advised to discard the product after opening if it is not used within a specified time frame, although the exact duration is not provided.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Brush Buddies Crayola 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 Crayola 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.