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Brushbuddies Shopkins Anticavity Fluoride

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 0.0225 g/100 g
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
December 3, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.0225 g/100 g
Other brand names
Dosage form
Mouthwash
Route
Oral
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 2016
Label revision date
December 3, 2016
Manufacturer
Ashtel Studio Inc
Registration number
part355
NDC root
70108-502
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

This medication is designed to help 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 over time. It's a simple step you can take to maintain a healthy smile.

Uses

You can use this product to help protect against cavities, which are small holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

Additionally, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for most users.

Dosage and Administration

To use this mouth rinse effectively, you should incorporate it into your daily routine right after brushing your teeth. For adults and children aged 6 years and older, start by shaking the bottle well to ensure the ingredients are mixed properly. Measure out 15 mL, which is equivalent to 3 teaspoonfuls, and then rinse or gargle it in your mouth for 30 seconds before spitting it out.

It's important to supervise younger children while they are brushing their teeth and using the rinse until they develop good habits. Remember, this mouth rinse is not meant to be swallowed, so make sure to spit it out after use. Following these steps will help you maintain good oral hygiene.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

If you accidentally swallow more of this product than intended for brushing, it’s important to seek professional help or contact a Poison Control Center right away. This is a serious situation that requires immediate attention.

Always use the product as directed to minimize the risk of adverse effects. If you have any concerns about how this product may affect you, please consult with a healthcare professional.

Warnings and Precautions

If you accidentally swallow more than the amount used for brushing, it’s important to seek professional help or contact a Poison Control Center right away. This is crucial to ensure your safety and address any potential risks.

While there are no specific general precautions or laboratory tests mentioned, always stay informed about how to use your products safely. If you experience any unusual symptoms or have concerns, don’t hesitate to stop using the product and consult your doctor for guidance. Your health and safety are the top priority.

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

When it comes to using this medication during pregnancy, there is currently no information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before starting or continuing this medication. They can help you understand any potential risks and make informed decisions about your treatment options. Always prioritize your health and the health of your baby by seeking professional guidance.

Lactation Use

If you are breastfeeding, it's important to know that there is no specific information available regarding the effects of this medication on nursing mothers or their breast milk. This means that the potential impact on your milk production or your baby's health is not clearly defined.

As always, it's best to consult with your healthcare provider for personalized advice and to discuss any concerns you may have about medications while breastfeeding. They can help you weigh the benefits and risks based on your individual situation.

Pediatric Use

It's important to establish good oral hygiene habits for your child. For children aged 6 years and older, you can encourage them to use this product daily after their regular brushing. However, it's essential to supervise their brushing until they develop strong habits on their own. This way, you can ensure they are using the product correctly 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 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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place, away from direct sunlight. This helps maintain its integrity and effectiveness. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Proper storage and careful handling are key to ensuring that the product remains safe and effective for your use.

Additional Information

You should take care when using this product. It is meant for oral use only, so do not swallow the rinse. If you accidentally swallow more than what is needed for brushing, seek professional help or contact a Poison Control Center right away. Keep this product out of reach of children and supervise their brushing until they develop good habits.

FAQ

What is the primary use of this drug?

This drug helps protect against cavities.

Who can use this drug?

Adults and children 6 years and older can use this drug.

How should I use this drug?

Use it daily after brushing your teeth. Shake well before each use, rinse or gargle for 30 seconds with 15 mL (3 teaspoonful), and then spit it out.

What should I do if I accidentally swallow more than the recommended amount?

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

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Is there any information regarding use during pregnancy or nursing?

No specific information regarding use during pregnancy or nursing is provided.

How should I store this drug?

Store it in a cool and dry place away from direct sunlight.

What precautions should I take when using this drug with children?

Supervise children's brushing until good habits are established and keep the drug out of reach of children.

Packaging Info

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

Packaging configurations for Brushbuddies Shopkins Anticavity Fluoride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the protection against dental cavities.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 6 years and older, the recommended dosage is to use the product daily following the normal brushing routine. Prior to use, it is essential to shake the bottle well to ensure proper mixing of the solution.

The administration involves rinsing or gargling with 15 mL (equivalent to 3 teaspoonfuls) of the solution for a duration of 30 seconds, after which the user should spit out the rinse. It is important to supervise children's brushing until they have established good oral hygiene habits. Additionally, users should be cautioned not to swallow the rinse.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

If more than the recommended amount for brushing is accidentally swallowed, it is imperative to seek professional medical assistance or contact a Poison Control Center immediately. This action is crucial to ensure the safety and well-being of the patient.

No additional general precautions or laboratory tests are specified in the insert. Healthcare professionals should remain vigilant and monitor for any adverse effects or unusual symptoms that may arise during the use of this product. In the absence of specific emergency medical help instructions or guidance on discontinuation, practitioners are encouraged to use their clinical judgment and consult relevant medical resources as needed.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. In the event of accidental ingestion of more than the recommended amount for brushing, it is imperative to seek professional medical assistance or contact a Poison Control Center immediately.

While specific adverse reactions were not detailed in the available data, the importance of adhering to the recommended usage guidelines cannot be overstated to prevent serious outcomes.

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 Brushbuddies Shopkins Anticavity Fluoride (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Brushbuddies Shopkins Anticavity Fluoride.
Details

Pediatric Use

Pediatric patients aged 6 years and older are advised to use the product daily following their normal brushing routine. It is essential for caregivers to supervise children's brushing until effective oral hygiene habits are established.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. It is advisable to monitor any pregnant patients closely and to discuss alternative treatment options if necessary.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there are no data on the excretion of this medication in human breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment.

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 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 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 medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool and dry environment, ensuring it is protected from direct sunlight to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to seek professional help or contact a Poison Control Center immediately if more than the recommended amount for brushing is accidentally swallowed. It is essential to keep the product out of reach of children and to supervise children's brushing until proper habits are established. Patients should be instructed not to swallow the rinse.

Drug Information (PDF)

This file contains official product information for Brushbuddies Shopkins 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 Brushbuddies Shopkins 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.