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Dentalclean Advance Pro

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Active ingredient
Sodium Fluoride 2.4 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2026
Label revision date
March 16, 2026
Active ingredient
Sodium Fluoride 2.4 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 2026
Label revision date
March 16, 2026
Manufacturer
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
Registration number
M021
NDC root
84035-013

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 product is designed to help you maintain good oral health by preventing cavities and gingivitis (inflammation of the gums). It works by interfering with the harmful effects of plaque, which is a sticky film of bacteria that can lead to gum disease. Additionally, it builds protection against painful sensitivity in your teeth, which can occur when exposed to cold, heat, acids, sweets, or even touch.

By using this product regularly, you can support your dental health and reduce the risk of discomfort and dental issues. It's a helpful tool in your daily oral care routine to keep your smile healthy and strong.

Uses

You can use this product to help keep your teeth healthy in several ways. It aids in the prevention of cavities, which are small holes in your teeth caused by decay. Additionally, it helps prevent gingivitis, a common gum disease that can lead to more serious dental issues if not treated.

This product also works to interfere with the harmful effects of plaque, a sticky film of bacteria that can contribute to gingivitis. Furthermore, it builds increasing protection against painful sensitivity in your teeth, which can occur when exposed to cold, heat, acids, sweets, or even just contact. By using this product regularly, you can help maintain your oral health and comfort.

Dosage and Administration

To use this dental product effectively, you should apply at least a 1-inch strip onto a soft-bristled toothbrush. Brush your teeth thoroughly for at least one minute, twice a day—once in the morning and once in the evening. It's important to focus on all sensitive areas of your teeth to ensure you get the best results.

If you are using this product for a child under 12 years old, it's best to consult a dentist for specific recommendations tailored to their needs. Following these guidelines will help maintain good oral health and address any sensitivity issues you may have.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known restrictions or risks that would prevent you from using it safely. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You may experience some side effects while using this product. Sensitive teeth can be a sign of a more serious issue, so it's important to consult a dentist if this occurs. Additionally, if you notice gingivitis (inflammation of the gums), bleeding, or redness that lasts longer than two weeks, or if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between your teeth, seek dental care immediately. These symptoms could indicate periodontitis, a serious gum disease.

If you accidentally swallow more than the recommended amount, it's crucial to get medical help or contact a Poison Control Center right away. Your health and safety are important, so don't hesitate to reach out for assistance if you have any concerns.

Warnings and Precautions

When using this product for tooth sensitivity, it's important not to exceed 4 weeks of use unless your dentist advises otherwise. If your sensitivity continues or worsens, please stop using the product and consult your dentist, as this could indicate a more serious issue that requires attention.

Keep this product out of reach of children. If a child accidentally swallows more than the amount used for brushing, seek medical help immediately or contact a Poison Control Center. Additionally, if you experience persistent gingivitis (gum inflammation), bleeding, or redness for more than 2 weeks, or if you notice painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between your teeth, stop using the product and consult your dentist right away.

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 obvious, but if you experience any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be cautious when it comes to your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Given this lack of information, you should consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 12 years old, it's important to consult a dentist before using this medication. This ensures that the treatment is appropriate and safe for their age group. Always prioritize professional guidance when it comes to your child's health.

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 for personalized advice. 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, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you are undergoing. This way, you can avoid any potential issues and receive the best care possible.

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 product but do not use it within a specified time frame, please discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should apply at least a 1-inch strip of the product onto a soft-bristled toothbrush and brush your teeth thoroughly for at least 1 minute, twice a day (morning and evening), or as directed by your dentist. Make sure to focus on all sensitive areas of your teeth, and remember not to swallow the product. If you are under 12 years old, consult a dentist before use.

If you experience ongoing sensitivity, gingivitis (inflammation of the gums), bleeding, or redness that lasts more than two weeks, stop using the product and consult your dentist. Additionally, seek dental advice if you notice painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between your teeth, as these could indicate a serious gum disease called periodontitis. Always keep the product out of reach of children, and if more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the primary use of this product?

This product aids in the prevention of cavities, helps prevent gingivitis, and builds protection against painful sensitivity of the teeth.

How should adults and children 12 years and older use this product?

Apply at least a 1 inch strip onto a soft bristled toothbrush and brush thoroughly for at least 1 minute twice a day.

What should children under 12 years of age do?

Consult a dentist before use.

What should I do if I experience sensitivity that persists or worsens?

Stop use and ask a dentist if the sensitivity problem persists or worsens.

Are there any warnings associated with this product?

Yes, stop use and consult a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks, or if you have painful or swollen gums.

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

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

How should this product be stored?

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

Is this product safe for nursing mothers?

There are no specific warnings or recommendations regarding its use by nursing mothers.

Packaging Info

Below are the non-prescription pack sizes of Dentalclean Advance Pro (sodium fluoride 0.24%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dentalclean Advance Pro.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the prevention of dental cavities and gingivitis. It aids in interfering with the harmful effects of plaque associated with gingivitis. Additionally, this drug builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, a minimum of a 1-inch strip of the product should be applied to a soft-bristled toothbrush. Patients are advised to brush their teeth thoroughly for at least 1 minute, twice daily, in the morning and evening, or as directed by a dentist. It is important to ensure that all sensitive areas of the teeth are adequately brushed.

For children under 12 years of age, consultation with a dentist is recommended prior to use.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

When utilizing this product for sensitivity, it is imperative that the duration of use does not exceed four weeks unless specifically recommended by a dentist. Should the sensitivity issue persist or worsen during this period, it is essential to discontinue use and consult a dentist, as sensitive teeth may indicate an underlying condition requiring prompt dental intervention.

In addition, if symptoms such as gingivitis, bleeding, or redness continue for more than two weeks, it is advised to stop use and seek dental advice. Patients should also be vigilant for signs of periodontitis, which may include painful or swollen gums, pus emanating from the gum line, loose teeth, or an increase in spacing between teeth. These symptoms warrant immediate consultation with a dental professional.

This product must be kept out of reach of children. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Overall, the safety and efficacy of this product are contingent upon adherence to these warnings and precautions. Regular monitoring of oral health and prompt reporting of any concerning symptoms to a healthcare provider are crucial for maintaining dental well-being.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious reactions warrant immediate attention and include symptoms indicative of potential dental issues. Sensitive teeth may signal a serious underlying problem that requires prompt evaluation by a dentist.

Patients should discontinue use and consult a dentist if they experience persistent gingivitis, bleeding, or redness lasting more than two weeks. Additionally, symptoms such as painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth may suggest periodontitis, a serious form of gum disease, and necessitate urgent dental care.

In the event that more than the recommended amount is accidentally swallowed, patients are advised to seek medical assistance or contact a Poison Control Center without delay.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dentalclean Advance Pro (sodium fluoride 0.24%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dentalclean Advance Pro.
Details

Pediatric Use

Pediatric patients under 12 years of age should be advised to consult a dentist prior to use. This recommendation is essential to ensure appropriate dental care and management in this age group.

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 potential 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 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. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 symptoms of overdosage may vary, and prompt evaluation is necessary to determine the appropriate management strategy. The management of overdosage will depend on the specific circumstances and the amount ingested.

In all cases of suspected overdosage, it is essential to monitor the patient closely and provide supportive care as needed.

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 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 individuals.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, away from extreme temperatures, and must be protected from freezing.

To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use. Additionally, any unused product should be discarded after opening if it is not utilized within the specified time frame.

Additional Clinical Information

Patients aged 12 years and older should apply at least a 1-inch strip of the product onto a soft-bristled toothbrush and brush thoroughly for at least 1 minute, twice daily, or as directed by a dentist. It is important to ensure that all sensitive areas of the teeth are brushed, and the product should not be swallowed. For children under 12 years of age, consultation with a dentist is advised.

Clinicians should counsel patients to discontinue use and seek dental advice if sensitivity persists or worsens, if gingivitis, bleeding, or redness lasts more than two weeks, or if symptoms such as painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth occur, as these may indicate periodontitis. Additionally, the product should be kept out of reach of children, and if more than the recommended amount is swallowed, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Dentalclean Advance Pro, 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 Dentalclean Advance Pro, 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

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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.