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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
September 25, 2019
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
September 25, 2019
Manufacturer
Nutrix, 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 be especially important for maintaining good oral health. By using this product, you can take an active step in reducing the risk of cavities and promoting a healthier smile.

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. Regular use can be an effective way to maintain a healthy smile.

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 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 harmful.

Currently, 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 medications responsibly.

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 a serious situation, and prompt action is necessary to ensure your safety. Always use the product as directed to avoid any potential risks.

Warnings and Precautions

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

Always use the product as directed to avoid any complications. If you have any concerns or experience unusual symptoms, don’t hesitate to stop using the product and call your doctor for further advice. Your health and safety are the top priority.

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

There is currently no specific information available regarding the use of SMILE DIRECT CLUB sodium fluoride toothpaste during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product's guidelines.

If you are pregnant or planning to become pregnant, it's always a good idea to consult with your healthcare provider before using any new products, including toothpaste, to ensure they are safe for you and your baby.

Lactation Use

Currently, there is no specific information available about the use of SMILE DIRECT CLUB sodium fluoride toothpaste for nursing mothers or during lactation (the period of breastfeeding). This means that if you are breastfeeding, you may want to consult with your healthcare provider for personalized advice regarding the use of this toothpaste and any potential effects on your milk production or your nursing infant. It's always best to prioritize safety and get professional guidance when it comes to products used during 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, ideally after each meal or at least twice a day, following the guidance 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 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

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 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 you understand how to manage your treatment effectively.

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 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 it after use to maintain safety and quality. Following these simple guidelines will help you use 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.

Who can use this drug?

Adults and children 2 years of age and older can use this drug. For children under 2 years, consult a dentist or doctor.

How should I 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 if a child under 6 accidentally swallows this drug?

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Are there any contraindications for this drug?

No specific contraindications are listed for this drug.

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

Instruct children under 6 in good brushing and rinsing habits to minimize swallowing, and supervise them until they can use it without assistance.

How should I store this drug?

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

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

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

Are there any known drug interactions?

No specific drug interactions are mentioned.

What should I do if I have questions about using this drug?

Consult your dentist or doctor for any questions or concerns regarding the use of this drug.

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 medical assistance or contact a Poison Control Center without delay. 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 mitigate the risk of accidental overdose.

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.

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

Geriatric Use

There is no specific information available 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 SMILE DIRECT CLUB sodium fluoride toothpaste during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product during pregnancy.

Lactation

There is no specific information regarding the use of SMILE DIRECT CLUB sodium fluoride toothpaste in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

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 individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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 provide the patient with information regarding the amount ingested and the time of ingestion to facilitate appropriate medical response.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided 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 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 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, it is important to discard the product after opening to maintain safety and efficacy.

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 the risk of 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.

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.