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Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor

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Active ingredient
Sodium Fluoride 0.05 g/100 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
September 25, 2024
Active ingredient
Sodium Fluoride 0.05 g/100 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
September 25, 2024
Manufacturer
Ashtel Studios, Inc
Registration number
M021
NDC root
70108-103

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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 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, and gargle or swish it around in your mouth 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 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 prioritize safety and follow the usage instructions carefully.

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 what is used for rinsing, you should seek professional help or contact a Poison Control Center right away. This precaution helps ensure safety and prevent any potential harm.

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 immediately.

While there are no specific general precautions or laboratory tests mentioned, always use this 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 medication than intended for rinsing, 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 if you experience any unusual symptoms, it’s crucial to get medical attention as soon as possible. Remember, it’s always better to be safe and get help if you’re unsure about your situation.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about 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’s important to discuss any medications you are considering with your healthcare provider. They can help you understand the best options for 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 the use of this product while nursing. Additionally, there are no known concerns about this product being passed into breast milk or any associated risks for your infant. Always consult with your healthcare provider if you have any questions or concerns 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 hygiene.

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any medications with your healthcare provider. They can help determine the best approach for your individual health needs and ensure that any potential risks are managed effectively. Always keep your doctor informed about all medications you are taking, as this can help prevent any adverse effects.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance. They can provide you with the necessary information tailored to your specific situation.

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, and there are no special monitoring or precautions outlined for patients with liver impairment.

However, it's always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice and ensure that any medications you take are safe for your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best 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. Following these guidelines will help you use the product safely and effectively.

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 children as needed, and if your child is under 6, consult with a dentist or doctor for guidance.

FAQ

What is the main use of this product?

This product helps protect teeth against cavities.

Who can use this product?

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

What should I do before using this product?

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

How do I use this product?

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 age restrictions for this product?

Keep 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 product?

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 product?

No contraindications are listed for this product.

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

There are no specific warnings or recommendations regarding use during pregnancy or by nursing mothers.

How should I store this product?

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 Squishmallows Anticavity Fluoride Mint Flavor (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor.
Details

Drug Information (PDF)

This file contains official product information for Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

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.

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 to ensure that the rinse is not swallowed. Following the rinsing procedure, patients should refrain from eating or drinking for 30 minutes to maximize the effectiveness of the rinse.

For children under 6 years of age, consultation with a dentist or doctor is recommended before use. Additionally, supervision of children during the rinsing process is advised to ensure safe and proper administration.

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 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.

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 aware of the potential risks 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 have not been detailed in clinical trials or postmarketing experiences, the importance of adhering to safety guidelines cannot be overstated. Proper usage is essential to minimize the risk of serious outcomes.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

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

Packaging configurations for Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor.
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 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.

Pregnancy

There is no specific information available 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 using this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems.

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 rinsing, it is crucial to seek professional medical 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 important, although specific symptoms are not detailed in the provided information. Therefore, healthcare professionals should remain vigilant and assess the patient for any unusual signs or reactions following an overdosage incident.

In summary, immediate professional help 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 appropriate response in case of an emergency.

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 is recommended, and consultation with a dentist or doctor is advised for those under 6 years of age.

Drug Information (PDF)

This file contains official product information for Brush Buddies Squishmallows Anticavity Fluoride Mint Flavor, 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 Squishmallows Anticavity Fluoride Mint Flavor, 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.