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Brush Buddies Cookies N Cream Ice Cream Flavored Anticavity Fluoride

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Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
September 17, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.243 g/100 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
September 17, 2025
Manufacturer
Ashtel Studios, Inc.
Registration number
M021
NDC root
70108-237
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Brush Buddies Cookies n Cream is a dental product designed to help protect your teeth and roots against cavities. It offers a tasty way to support your oral health while promoting good dental hygiene. By using this product, you can take an enjoyable step towards maintaining a healthier smile.

Uses

This medication is designed to help protect your teeth and roots from cavities, which can lead to decay and other dental issues. By using this product, you can take an important step in maintaining your oral health and preventing potential problems down the line.

It's reassuring to know that there are no teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for those concerned about the impact on overall health while focusing on dental care.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly after meals or at least twice a day. If you're an adult or a child aged 2 years and older, make sure to follow these guidelines or any specific instructions given by your dentist. Remember, do not swallow the toothpaste.

For children aged 2 to 6 years, use only a pea-sized amount of toothpaste to help minimize the chance of swallowing. It's also a good idea to supervise their brushing and rinsing until they develop good habits. If your child is under 2 years old, be sure to consult a dentist or doctor for advice on dental care.

What to Avoid

It's important to ensure that you use this product safely. Keep it out of reach of children under 6 years old to prevent any accidental ingestion. If you or someone else accidentally swallows more than what is needed for brushing, seek professional help or contact a Poison Control Center right away. This will help ensure everyone's safety and well-being.

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 the amount used for brushing, 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, 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 to prevent accidental ingestion. If you or someone else accidentally swallows more than what is needed for brushing, seek professional help or contact a Poison Control Center immediately.

While there are no specific general precautions or laboratory tests mentioned, always use the product as directed. If you experience any unusual symptoms or have concerns, it's best to consult your doctor for guidance.

Overdose

If you accidentally swallow more of the product than what is typically used for brushing your teeth, 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’re unsure.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits of using this medication while pregnant have not been clearly established.

If you are pregnant or planning to become pregnant, it is essential to discuss any medications you are considering with your healthcare provider. They can help you understand the potential risks and make informed decisions that prioritize your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. For children aged 2 to 6 years, use only a pea-sized amount to help minimize the risk of swallowing, and make sure to supervise their brushing and rinsing until they develop good habits.

If your child is under 2 years old, it's best to consult with a dentist or doctor before use to ensure their safety and proper care.

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 the drug insert does not provide guidelines tailored for elderly patients.

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 assess individual health needs and determine the best approach to treatment, ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective 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 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 any unused portion 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 use.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market. If you have any questions about how this medication is used or its effects, be sure to consult your healthcare provider.

FAQ

What is Brush Buddies Cookies n Cream used for?

Brush Buddies Cookies n Cream helps protect teeth and roots against cavities.

What age group can use Brush Buddies Cookies n Cream?

It is suitable for adults and children 2 years and older.

How should I use Brush Buddies Cookies n Cream?

You should brush your teeth thoroughly after meals or at least twice a day, or use as directed by a dentist.

What should I do if a child under 2 years wants to use it?

Consult a dentist or doctor before use for children under 2 years of age.

Is there a risk of swallowing Brush Buddies Cookies n Cream?

You should not swallow it. For children 2 to 6 years, use a pea-sized amount and supervise brushing to minimize swallowing.

What should I do if I accidentally swallow more than used for brushing?

Seek professional help or contact a Poison Control Center immediately.

Are there any contraindications for using Brush Buddies Cookies n Cream?

No contraindications are listed for this product.

How should I store Brush Buddies Cookies n Cream?

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

Are there any warnings for using Brush Buddies Cookies n Cream?

Keep it out of reach of children under 6 years of age.

Is Brush Buddies Cookies n Cream safe to use during pregnancy or while nursing?

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

Packaging Info

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

Packaging configurations for Brush Buddies Cookies N Cream Ice Cream Flavored Anticavity Fluoride.
Details

Drug Information (PDF)

This file contains official product information for Brush Buddies Cookies N Cream Ice Cream Flavored Anticavity Fluoride, 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 and roots against cavities.

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

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children aged 2 to 6 years, a pea-sized amount of the product should be used to minimize the risk of swallowing. Caregivers should supervise the brushing and rinsing process until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist or doctor prior to use to ensure safety and appropriateness of the product.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, 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 that used for brushing, it is crucial to seek professional medical assistance or contact a Poison Control Center immediately.

No specific general precautions or laboratory tests have been identified for this product. Healthcare professionals should remain vigilant and ensure that patients are aware of the importance of adhering to these warnings to promote safe usage.

Side Effects

Patients should be advised to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of an amount greater than that used for brushing, it is imperative to seek professional help or contact a Poison Control Center immediately. This warning is crucial to ensure the safety of young children who may be at risk of serious adverse effects from improper use.

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 Cookies N Cream Ice Cream Flavored Anticavity Fluoride (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Brush Buddies Cookies N Cream Ice Cream Flavored Anticavity Fluoride.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children aged 2 to 6 years, it is recommended to use a pea-sized amount to minimize the risk of swallowing, and caregivers should supervise the child's brushing and rinsing until proper oral hygiene habits are established. For infants and children under 2 years of age, consultation with a dentist or doctor is advised prior to use.

Geriatric Use

There is no specific information 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this drug 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. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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 that healthcare professionals take immediate action. If a patient accidentally swallows an amount greater than what is typically used for brushing, it is crucial to seek professional assistance without delay.

Healthcare providers should advise the patient or caregiver to contact a Poison Control Center immediately for guidance on the appropriate steps to take. Prompt intervention is essential to mitigate potential adverse effects associated with overdosage.

Monitoring for symptoms related to overdosage is also recommended, although specific symptoms are not detailed in the provided information. Therefore, vigilance in assessing the patient's condition and any emerging symptoms is advised.

In summary, immediate professional consultation and contact with a Poison Control Center are the recommended actions in the case of 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 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 recommended for brushing, 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 route of administration for the product is dental. There is no additional information available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Brush Buddies Cookies N Cream Ice Cream Flavored Anticavity Fluoride, 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 Cookies N Cream Ice Cream Flavored Anticavity Fluoride, 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.