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Smilebar Whitening

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Sodium Fluoride 2.43 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
December 8, 2020
Active ingredient
Sodium Fluoride 2.43 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
December 8, 2020
Manufacturer
Smilebar
Registration number
part355
NDC root
73449-001

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Drug Overview

This Whitening Toothpaste with Fluoride and Baking Soda is specially designed to support your clear aligner treatment. It helps protect against cavities while also whitening your teeth by effectively removing surface stains, tartar, and plaque. Additionally, this toothpaste works to restore enamel and protect your gums, making it a comprehensive choice for maintaining oral health during your orthodontic journey.

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, so you can feel confident in its safety for use.

Dosage and Administration

To keep your teeth healthy, make sure to brush them thoroughly after meals or at least twice a day, unless your dentist advises otherwise. It's important to remember not to swallow the toothpaste, as it is not meant to be ingested. Additionally, this product is not suitable for children under the age of 6, so please ensure that it is kept out of their reach. Following these guidelines will help you maintain good oral hygiene.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure safe use.

Side Effects

It's important to keep this product out of reach of children under 6 years old. If a large amount is swallowed—more than what would typically be used for brushing—seek medical help immediately or contact a Poison Control Center.

Always be aware of how to use this product safely to avoid any potential risks.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old to prevent accidental ingestion. If a large amount—more than what would typically be used for brushing—is swallowed, you should seek medical help immediately or contact a Poison Control Center.

Always be cautious and monitor for any unusual reactions. If you experience any concerning symptoms, stop using the product and call your doctor for further guidance. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

If you accidentally swallow a large amount of this product—more than what you would typically use for brushing your teeth—it’s important to seek medical help immediately. You can also contact a Poison Control Center for guidance.

Signs of an overdose may not always be obvious, but if you experience unusual symptoms or feel unwell after swallowing too much, don’t hesitate to reach out for help. Remember, it’s always better to be safe and get professional advice if you’re unsure.

Pregnancy Use

There is currently no specific information available about the use of Smilebar Whitening Toothpaste with Fluoride 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

If you are breastfeeding, it's important to note 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 medication out of reach of children under 6 years old. For safety reasons, children in this age group should not use it at all, as it is not intended for them. Additionally, make sure that your child understands not to swallow the medication, as it is not safe for them to do so. Always supervise young children when they are around medications to prevent any accidental ingestion.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine if this medication is appropriate and whether any adjustments are needed based on individual health conditions.

Always keep in mind that older adults may have different health needs, and medications can affect them differently. Regular check-ins with your healthcare provider can ensure that any treatment remains safe and effective.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have 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 of your product, store it at room temperature and avoid freezing it, as extreme cold can damage it. When not in use, make sure to keep the tube tightly closed to maintain its integrity. Remember to discard the product after opening to ensure safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication as directed by your dentist, applying it through a dental route. It's important to brush your teeth thoroughly after meals or at least twice a day to maintain oral health. If you have any questions about how to use this product, don't hesitate to ask your dentist for guidance.

FAQ

What is Whitening Toothpaste with Fluoride + Baking Soda used for?

It is designed for clear aligner treatment and helps protect against cavities.

How does this toothpaste work?

It whitens teeth by removing surface stains, tartar, and plaque, while also restoring enamel and protecting gums.

What are the instructions for using this toothpaste?

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

Is this toothpaste safe for children?

No, it is not for children under 6 years of age. Keep it out of their reach.

What should I do if a large amount of toothpaste is swallowed?

Get medical help or contact a Poison Control Center right away.

Are there any contraindications for this toothpaste?

No specific contraindications are listed for this product.

How should I store this toothpaste?

Store it at room temperature, do not freeze, and keep the tube tightly closed when not in use.

Is there any information about using this toothpaste during pregnancy or while nursing?

No specific information is provided regarding its use during pregnancy or lactation.

Packaging Info

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

Packaging configurations for Smilebar Whitening.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This whitening toothpaste is formulated with fluoride and baking soda, specifically designed for use during clear aligner treatment. It effectively whitens teeth by removing surface stains, tartar, and plaque while also protecting gums. Additionally, it fights cavities and aids in the restoration of enamel. The product is packaged in a net weight of 3.4 oz (96 g) and is distributed by SmileBar, located at 303 Columbus Ave, Boston, MA 02116.

Uses and Indications

This drug is indicated for the protection against cavities.

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to brush their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to emphasize that the product should not be swallowed. Additionally, this product is not recommended for use in children under the age of 6.

Contraindications

There are no contraindications listed for this product. It is important to evaluate each patient's individual circumstances and medical history when considering its use.

Warnings and Precautions

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

In the event that a large amount, exceeding the quantity typically used for brushing, is swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be aware of the following warnings 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 large amount, exceeding the quantity typically used for brushing, is swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Smilebar Whitening.
Details

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. It is important to keep the product out of reach of children in this age group. Additionally, the medication is not intended for swallowing by children under 6 years.

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 specific information regarding the use of Smilebar Whitening Toothpaste with Fluoride during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that pregnant patients consult their healthcare provider for personalized guidance.

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.

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 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 if a large amount of the product, exceeding the quantity typically used for brushing, is ingested. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay.

Prompt intervention is essential to manage potential complications associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. It is imperative to follow established protocols for the treatment of overdosage to ensure patient safety and effective resolution of symptoms.

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 a tube format. It should be stored at room temperature, ensuring that it is not exposed to freezing conditions. To maintain product integrity, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Patients are advised to brush their teeth thoroughly after meals or at least twice a day, or to use the product as directed by a dentist. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Smilebar Whitening, 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 Smilebar Whitening, 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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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.