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Dentree

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.22 g/100 mL
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2012
Label revision date
April 20, 2020
Active ingredient
Sodium Fluoride 0.22 g/100 mL
Other brand names
Dosage form
Gel, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2012
Label revision date
April 20, 2020
Manufacturer
E-SOUP Co. , Ltd.
Registration number
part355
NDC root
76170-102

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 drug is designed to help you maintain good oral health by preventing dental cavities, which are small holes in your teeth caused by decay. In addition to cavity prevention, it also helps reduce halitosis (bad breath), making your breath fresher. Furthermore, this drug offers tooth whitening benefits, helping to enhance the appearance of your smile.

Uses

You can use this product to help keep your teeth healthy and bright. It aids in the prevention of dental cavities, which means it helps protect your teeth from decay. Additionally, it reduces halitosis, or bad breath, so you can feel more confident in your smile.

If you're looking to enhance the appearance of your teeth, this product also offers tooth whitening benefits, helping to brighten your smile and improve your overall dental aesthetics.

Dosage and Administration

To use this dental foam effectively, start by shaking the container well. If you are an adult or a child aged 6 years or older, you can either use it without a toothbrush or with one. For the brushless method, pump the foam 2-3 times onto your toothbrush or directly into your mouth. Gurgle the foam around your mouth for about 30 seconds, then rinse your mouth several times with clean water to ensure your teeth are clean.

If you prefer to use a toothbrush, gurgle the foam first for about 30 seconds, then use the toothbrush to clean your teeth before rinsing. If you have a child under 6 years old, it’s important to consult a dentist or physician for guidance on how to use this product safely.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, risks of abuse or misuse, or concerns about dependence (which means relying on a substance to function normally) mentioned in the information provided. Additionally, there are no instructions indicating that you should avoid taking or using this medication. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

It's important to keep this product out of reach of children. If you accidentally swallow more than what is typically used for brushing your teeth, seek medical help or contact a Poison Control Center immediately. This ensures your safety and addresses any potential concerns quickly.

Warnings and Precautions

It's important to keep this product out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows more than what is typically used for brushing, seek medical help immediately or contact a Poison Control Center.

Always use this product as directed to ensure safety and effectiveness. If you have any concerns or experience unusual symptoms, stop using it and call your doctor for further guidance.

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 immediately or contact a Poison Control Center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose may not be immediately obvious, but if you experience any unusual symptoms, don’t hesitate to reach out for assistance. Always err on the side of caution when it comes to your health.

Pregnancy Use

When considering the use of DENTREE sodium fluoride gel or dentifrice during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the potential risks and benefits of using this product while pregnant have not been clearly established.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including dental care items like fluoride gel or dentifrice. They can provide personalized advice based on your health needs and circumstances.

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 use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

As a precaution, you may want to consult with your healthcare provider to discuss any potential risks and to ensure that you are making the best choices for both you and your infant. Always prioritize open communication with your doctor about any medications you are considering while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children. If your child accidentally swallows more than the amount used for brushing, seek medical help or contact a Poison Control Center immediately.

For children aged 6 years and older, you can use the product by shaking the container and applying 2-3 pumps onto a toothbrush or directly into their mouth. They should gurgle the foam for about 30 seconds and then rinse with clean water several times. If your child is under 6 years old, please consult a dentist or physician before use to ensure safety.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any concerns with your healthcare provider. They can help determine the best approach for you, considering any potential safety concerns or necessary adjustments in dosage.

If you or a loved one is an older adult, make sure to keep your healthcare team informed about all medications being taken and any changes in health status. This way, they can provide the safest and most effective care tailored to your needs.

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.

It's always best to consult with your healthcare provider about your individual situation, as they can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use. If you have any questions about disposal or other safety measures, refer to the guidelines provided with your product.

Additional Information

This medication is administered through dental means, which means it is used in a dental setting. It's important to keep this product out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows more than what is typically used for brushing, seek medical help or contact a Poison Control Center immediately.

FAQ

What does this drug do?

This drug aids in the prevention of dental cavities, reduces halitosis (bad breath), and provides tooth whitening.

How should adults and children 6 years and older use this drug?

You can use it brushless by shaking the container and pumping 2-3 times onto a toothbrush or into your mouth, gurgling the foam for about 30 seconds, and rinsing with clean water. Alternatively, you can gurgle first and then use a toothbrush before rinsing.

What should I do if a child under 6 years old needs to use this drug?

You should ask a dentist or physician for guidance.

Are there any warnings associated with this drug?

Yes, keep it out of reach of children. If more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center immediately.

Is there any information about drug interactions?

No specific drug interactions are mentioned for this drug.

What should I know about using this drug during pregnancy or while nursing?

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

How should this drug be stored?

Store the drug at room temperature.

Packaging Info

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

Packaging configurations for Dentree.
Details

Drug Information (PDF)

This file contains official product information for Dentree, 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 SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "D" on one side and "34089" on the opposite side. It contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It aids in reducing halitosis and is also effective for tooth whitening.

Limitations of Use: This product is intended for use as part of a comprehensive oral hygiene regimen and should not be used as a substitute for regular dental care.

Dosage and Administration

For adults and children aged 6 years and older, the recommended method of administration involves two options: brushless and with a brush.

In the brushless method, the healthcare professional should instruct the patient to shake the container before use. The patient should then pump the foam 2-3 times onto a toothbrush or directly into the mouth. It is important to gurgle the foam inside the mouth for approximately 30 seconds. Following this, the patient should rinse the mouth thoroughly with clean water several times to ensure optimal cleanliness.

For the method with a brush, after gurgling the foam for about 30 seconds, the patient may use a toothbrush to clean the teeth before rinsing the mouth.

For children under 6 years of age, it is advised to consult a dentist or physician for appropriate guidance on usage.

Contraindications

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

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients should be advised to keep this product out of reach of children. In the event that more than the recommended amount for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

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 Dentree (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dentree.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is necessary.

For children aged 6 years and older, the recommended usage involves shaking the container before dispensing 2-3 pumps onto a toothbrush or directly into the mouth for gurgling. The foam should be gurgled for approximately 30 seconds, followed by rinsing with clean water multiple times to ensure proper cleanliness. If using a toothbrush, it is advised to brush after gurgling and before rinsing.

For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

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 DENTREE sodium fluoride gel, dentifrice during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. No dosage modifications or special precautions during pregnancy are indicated in the prescribing information.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any 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 data may be necessary to inform clinical decisions.

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 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, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount typically used for brushing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential. It is recommended that healthcare providers familiarize themselves with local Poison Control resources to ensure rapid access to expert guidance in such situations.

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 question.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals. Emphasizing the need for secure storage can help ensure the safety of children in the household.

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 at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients to keep the product out of reach of children. In the event that more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Dentree, 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 Dentree, 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.