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Shopkins Brush Buddies

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This product has been discontinued

Active ingredient
Sodium Fluoride 2.4 mg/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
December 31, 2019
Active ingredient
Sodium Fluoride 2.4 mg/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
December 31, 2019
Manufacturer
Ashtel Studios Inc.
Registration number
part355
NDC root
70108-005

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Drug Overview

This medication is designed to help protect your teeth and roots against cavities. By using it regularly, you can support your dental health and reduce the risk of tooth decay. It's an important part of maintaining a healthy smile and ensuring your teeth stay strong.

Uses

You can use this product to help protect your teeth and roots from cavities. By strengthening your dental health, it plays a crucial role in preventing tooth decay, ensuring that your smile stays healthy and bright. Regular use can contribute to better oral hygiene and overall dental well-being.

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, you should not swallow the toothpaste. For children under 6 years old, use only a pea-sized amount to help minimize the risk of swallowing. It's also a good idea to supervise young children while they brush their teeth until they develop good habits.

If your child is under 2 years old, it's best to consult with a dentist for advice on how to care for their teeth properly. Taking these steps will help ensure that you and your family maintain good oral health.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. While there are no listed contraindications, controlled substance classifications, or concerns about abuse or dependence, you should take care to avoid accidental ingestion. If you accidentally digest the medication, seek professional assistance or contact a poison control center immediately for guidance. Your safety is paramount, so please follow these instructions closely.

Side Effects

It's important to be aware of potential side effects when using this medication. You should keep it out of reach of children under 6 years old to prevent accidental ingestion. If you accidentally swallow more than the amount used for brushing, seek professional help or contact a poison control center right away.

While specific adverse reactions are not detailed here, always monitor how you feel after using the medication and consult your healthcare provider if you notice anything unusual. 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 old to prevent any accidental ingestion. If you or someone else accidentally swallows more than the amount used for brushing, it's crucial to seek professional help or contact a poison control center right away.

In the event of accidental digestion, you should also seek professional assistance or reach out to a poison control center immediately. Taking these precautions can help ensure safety and prevent any potential health issues.

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 think you may have taken too much.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to know that the safety of this product during pregnancy has not been established. There may be potential risks to your fetus, and further studies are needed to fully understand these risks. Therefore, you should consult your healthcare provider before using this product.

If your healthcare provider determines that you need to use it, do so only if it is clearly necessary. There are no specific dosage modifications provided for pregnant individuals, so it’s crucial to follow your healthcare provider's guidance closely.

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. For children aged 2 years and older, you should encourage them to brush their teeth thoroughly after meals or at least twice a day, following any specific instructions from your dentist. When helping younger children brush, use only a pea-sized amount to minimize the risk of swallowing.

For children under 2 years old, it's best to consult with a dentist before using this product. Additionally, make sure to supervise your child's brushing until they develop good habits on their own.

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, it’s important to consult with a healthcare provider before starting the medication. 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 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 plan.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this product as directed for dental care. For adults and children aged 2 years and older, brush your teeth thoroughly after meals or at least twice a day. It's important not to swallow the product; for children under 6, use only a pea-sized amount to minimize swallowing, and supervise their brushing until they develop good habits. If your child is under 2 years old, consult a dentist for guidance.

Always keep this product out of reach of children. If accidental ingestion occurs, seek professional help or contact a poison control center immediately. If you swallow more than the amount used for brushing, also seek professional assistance.

FAQ

What is the purpose of this product?

This product helps protect teeth and roots against cavities.

How should I use this product?

Brush your teeth thoroughly after meals or at least twice a day, or use as directed by a dentist. Do not swallow.

What should I do if a child under 2 years needs to use this product?

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

What precautions should I take for children under 6 years?

Keep this product out of reach of children under 6 years, and supervise their brushing until good habits are established.

What should I do in case of accidental swallowing?

If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately.

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established. Consult a healthcare provider if pregnant or planning to become pregnant.

What should nursing mothers know about this product?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

How should I store this product?

Store at room temperature and keep out of reach of children. Discard after opening.

Packaging Info

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

Packaging configurations for Shopkins Brush Buddies.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Brush Buddies toothpaste is a dental care product designed for oral hygiene. The formulation is intended to provide effective cleaning and protection for teeth. The product was introduced to the market with an effective date of July 22, 2016.

Uses and Indications

This drug is indicated for the protection of teeth and roots against cavities. It is designed to help maintain oral health by reducing the risk of dental caries.

Dosage and Administration

Adults and children aged 2 years and older should brush their teeth thoroughly after meals or at least twice a day, or as directed by a dentist. It is important to avoid swallowing the product. For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers are advised to supervise children's brushing until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist for appropriate guidance on usage.

Contraindications

Use is contraindicated in the event of accidental ingestion; in such cases, seek professional assistance or contact a poison control center immediately. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this product out of reach of children under 6 years of age to prevent accidental ingestion.

In the event of accidental swallowing of an amount greater than that typically used for brushing, it is crucial to seek professional help or contact a poison control center immediately. This precaution is essential to ensure the safety and well-being of the individual involved.

Should accidental digestion occur, immediate professional assistance or contact with a poison control center is also recommended. Prompt action in these situations is vital to mitigate any potential health risks.

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 to prevent accidental ingestion. In the event that a patient accidentally swallows more than the amount used for brushing, it is imperative to seek professional help or contact a poison control center immediately.

These warnings highlight the importance of proper usage and supervision, particularly in young children, to mitigate the risk of serious adverse events.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Shopkins Brush Buddies.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children under 6 years of age. For children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or to use as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years of age. It is important to supervise children's brushing until good oral hygiene habits are established. For children under 2 years of age, consultation with a dentist is advised before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus, and further studies are needed to determine safety. No specific dosage modifications are provided for pregnant individuals. This product should be used only if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

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

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 an overdosage, it is imperative that healthcare professionals take immediate action. If a patient accidentally ingests more than the recommended amount used for brushing, it is crucial to seek professional medical assistance or contact a poison control center without delay.

Symptoms of overdosage may vary, and prompt evaluation by a healthcare provider is essential to determine the appropriate management strategy. The healthcare professional should assess the patient's condition and provide supportive care as necessary.

In summary, any instance of overdosage requires urgent attention, and the recommended course of action is to contact a poison control center or seek professional help immediately.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with accidental digestion. In the event of such an occurrence, patients should be instructed to seek professional assistance or contact a poison control center immediately for guidance.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Additionally, it should be kept out of reach of children to ensure safety. Once opened, the product must be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The product is administered via the dental route. For adults and children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice daily, or as directed by a dentist. Patients should avoid swallowing the product, and for children under 6 years of age, a pea-sized amount should be used to minimize swallowing. Supervision of children's brushing is advised until proper habits are established. For children under 2 years, consultation with a dentist is recommended.

Clinicians should counsel patients to keep the product out of reach of children. In the event of accidental ingestion, it is crucial to seek professional assistance or contact a poison control center immediately. If more than the recommended amount is swallowed, professional help should also be sought.

Drug Information (PDF)

This file contains official product information for Shopkins Brush Buddies, 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 Shopkins Brush Buddies, 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.