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Smile Direct Club

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 2.4 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
January 16, 2020
Active ingredient
Sodium Fluoride 2.4 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
January 16, 2020
Manufacturer
Nutrix International, LLC
Registration number
part355
NDC root
73333-125

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

You may be interested to know that this medication is designed to help prevent dental cavities. It works by providing protection for your teeth, which can help maintain your oral health and reduce the risk of tooth decay. By using this product as directed, you can take an important step towards keeping your smile healthy and bright.

Uses

You can use this product to help prevent dental cavities, which are small holes in your teeth caused by decay. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing these issues. Keeping your teeth healthy is essential for maintaining a bright smile and overall well-being.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal or at least twice a day. This applies to both adults and children aged 2 years and older. If you're helping a child under 6, make sure to teach them good brushing and rinsing habits to reduce the chance of swallowing toothpaste. It's also a good idea to supervise younger children while they brush until they can do it on their own.

For children under 2 years of age, it's best to consult with a dentist or doctor before starting any dental care routine. This ensures that you’re taking the right steps for their dental health.

What to Avoid

It's important to ensure that any medication you use is kept safe and out of reach of children, especially those under 6 years of age. This precaution helps prevent accidental ingestion, which can be dangerous for young children.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow safety guidelines to protect yourself and others.

Side Effects

If you accidentally swallow more of this product than intended for brushing, it’s important to seek medical help or contact a Poison Control Center right away. This is crucial to ensure your safety and address any potential health concerns. Always use the product as directed to minimize risks.

Warnings and Precautions

If you accidentally swallow more of this product than intended for brushing your teeth, it’s important to seek medical help right away or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Always use this product as directed and be mindful of the amount you use. If you have any concerns or experience unusual symptoms, don’t hesitate to stop using the product and call your doctor for advice. Your health and well-being are important, so stay informed and cautious.

Overdose

If you accidentally swallow more of this product than what is typically used for brushing your teeth, it’s important to seek medical help right away. You can also contact a Poison Control Center for guidance.

Signs of an overdose may not be obvious, but if you experience any unusual symptoms, 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

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. Your doctor can help you make informed decisions that prioritize your health and the health of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it’s advisable to consult with your healthcare provider to discuss any potential risks or concerns related to your situation. They can help you make informed decisions about your health and your baby's well-being.

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, ideally after each meal or at least twice a day, following the advice of a dentist or doctor.

If your child is under 6, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing the product. Always supervise younger children while they brush their teeth until they can do it safely on their own. For children under 2 years old, it's best to consult with a dentist or doctor before use.

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. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

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 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that, based on the available information, this medication is not known to interfere with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always share your complete list of medications and any tests you may undergo to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and protect it from freezing. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you open the tube and do not use the contents within a specified time, please discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally. If you are giving it to children under 6 years old, make sure to teach them good brushing and rinsing habits to help prevent swallowing the medication. It's important to supervise younger children until they can use it safely on their own. If your child is under 2 years old, consult a dentist or doctor before use.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of dental cavities.

How should adults and children 2 years and older use this drug?

Brush your teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

What should I do for children under 6 years of age?

Instruct them in good brushing and rinsing habits to minimize swallowing, and supervise them until they can use it without help.

What should I do if a child under 2 years of age needs to use this drug?

Consult a dentist or doctor before use.

Are there any contraindications for this drug?

No specific contraindications are listed.

What should I do if more than the recommended amount is swallowed?

Get medical help or contact a Poison Control Center immediately.

How should this drug be stored?

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

Is there any information regarding the use of this drug during pregnancy or nursing?

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

Are there any known drug interactions?

No specific drug interactions are mentioned.

What precautions should be taken for children under 6 years of age?

Keep this drug out of reach of children under 6 years of age.

Packaging Info

Below are the non-prescription pack sizes of Smile Direct Club (sodium fluoride toothpaste). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Smile Direct Club.
Details

Drug Information (PDF)

This file contains official product information for Smile Direct Club, 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 data.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or doctor.

For children under 6 years of age, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

For children under 2 years of age, consultation with a dentist or doctor is recommended prior to use.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this age group. Additionally, it is advised to keep the product out of reach of children to avoid accidental ingestion or misuse.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is imperative to seek immediate medical assistance or contact a Poison Control Center. This precaution is critical to ensure the safety and well-being of the patient. Healthcare professionals should be vigilant in educating patients about the appropriate use of the product to prevent such occurrences.

Side Effects

Patients should be aware that if more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the potential seriousness of accidental ingestion and underscores the importance of adhering to the recommended usage guidelines to prevent adverse outcomes.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Smile Direct Club (sodium fluoride toothpaste). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Smile Direct Club.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Caregivers should instruct children under 6 in proper brushing and rinsing techniques to minimize the risk of swallowing. Supervision is advised until children are capable of using the product without assistance. For infants and children under 2 years of age, consultation with a dentist or doctor is recommended prior to 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

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 is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine the safety profile in this population.

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 of these patients.

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 critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information readily available when contacting medical professionals or poison control for guidance.

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 this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from extreme temperatures, and must be protected from freezing. To maintain the product's quality, the tube should be kept tightly closed when not in use. Additionally, it is recommended to discard the product after opening if it is not used within a specified time frame.

Additional Clinical Information

The medication is administered orally. Clinicians should instruct parents or guardians to teach children under 6 years of age proper brushing and rinsing techniques to minimize swallowing. Additionally, supervision is recommended for children until they are capable of using the product independently. For children under 2 years of age, it is advised to consult a dentist or doctor prior to use.

Drug Information (PDF)

This file contains official product information for Smile Direct Club, 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 Smile Direct Club, 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.