ADD CONDITION

items per page

Dentalclean Regenerator Sensitive Dental Gel with Flouride

Last content change checked dailysee data sync status

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 2024
Label revision date
May 1, 2024
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 2024
Label revision date
May 1, 2024
Manufacturer
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
Registration number
M021
NDC root
84035-002

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, helping to maintain oral health and reduce the risk of decay. By incorporating this into your dental care routine, 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.

Rest assured, this product does not have any known harmful effects on fetal development (teratogenic effects), making it safe for use during pregnancy.

Dosage and Administration

To keep your teeth healthy, it's important to brush 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 between 2 and 6 years old, make sure to teach them good brushing and rinsing habits to reduce the chance of swallowing toothpaste. It's best to supervise them while brushing and use only a pea-sized amount of toothpaste until they can brush on their own.

For children under 2 years of age, you should only use toothpaste if a dentist or doctor has specifically directed you to do so. Following these guidelines will help ensure that you and your family maintain good oral hygiene.

What to Avoid

It's important to ensure that any medication you use is kept safe and secure. Specifically, you should keep this medication out of reach of children under 6 years of age to prevent any accidental ingestion or misuse.

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

Side Effects

If you accidentally swallow more of this product than intended, especially beyond what is used for brushing your teeth, it’s important to seek medical help or contact a poison control center immediately. This is a serious situation that requires prompt attention.

Always use the product as directed to avoid any potential risks. If you have any concerns about its use, don’t hesitate to reach out to a healthcare professional for guidance.

Warnings and Precautions

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 immediately. This is crucial to ensure your safety and address any potential health risks.

Always use this product as directed. If you experience any unusual symptoms or reactions, stop using it and call your doctor for further advice. Your health and well-being are important, so don’t hesitate to reach out for help if you need it.

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 your local poison control center. This is crucial to ensure your safety and receive the appropriate care.

Signs of an overdose can vary, 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

You can use Dentalclean Regenerator Sensitive Dental Gel with Fluoride during pregnancy without specific warnings or dosage changes. The information available does not suggest that this product is contraindicated (not recommended) for pregnant individuals or that it poses any risk to your developing baby.

As always, it's a good idea to consult with your healthcare provider before using any new products during pregnancy to ensure they are safe for you and 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 use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your infant.

Pediatric Use

It's important to establish good dental hygiene habits for your child. 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 between 2 and 6 years old, make sure to supervise their brushing to help them develop proper techniques and minimize the risk of swallowing toothpaste. Use only a pea-sized amount of toothpaste until they can brush independently.

For children under 2 years of age, do not use toothpaste unless specifically directed by a dentist or doctor. Additionally, always keep toothpaste out of reach of children under 6 to ensure their safety.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 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 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 provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance and safety of your product, store it in a dry, cool place, away from direct sunlight. This helps maintain its integrity and effectiveness.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Proper storage and careful handling are key to ensuring that the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug aids in the prevention of dental cavities.

What should adults and children 2 years of age and older do when using this drug?

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

How should children aged 2 to 6 use this drug?

Instruct children in good brushing and rinsing habits to minimize swallowing, supervise as necessary, and use a pea-sized amount until they can use it without supervision.

Is this drug safe for children under 2 years of age?

Do not use this drug in children under 2 years of age unless directed by a dentist or doctor.

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

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

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

There are no specific warnings or contraindications regarding the use of this drug during pregnancy.

What precautions should be taken regarding children and this drug?

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

How should this drug be stored?

Store in a dry, cool place away from sunlight.

Packaging Info

Below are the non-prescription pack sizes of Dentalclean Regenerator Sensitive Dental Gel with Flouride (sodium fluoride 0.24%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dentalclean Regenerator Sensitive Dental Gel with Flouride.
Details

Drug Information (PDF)

This file contains official product information for Dentalclean Regenerator Sensitive Dental Gel with Flouride, 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 specific description details are provided in the text.

Uses and Indications

This drug is indicated for the prevention of dental cavities.

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

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 physician.

For children aged 2 to 6 years, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children under 6 years of age as necessary and recommend the use of a pea-sized amount of product until the child is capable of brushing without supervision.

In children under 2 years of age, the product should not be used unless specifically directed by a dentist or physician.

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, immediate medical assistance should be sought. Healthcare professionals are advised to contact a poison control center without delay to ensure appropriate management and intervention.

It is crucial for healthcare providers to educate patients on the importance of adhering to the recommended usage guidelines to prevent potential adverse effects associated with overconsumption. Monitoring for any signs of toxicity or adverse reactions is recommended in cases of accidental ingestion.

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 ingesting excessive amounts of the product, underscoring the importance of adhering to the recommended usage guidelines to prevent adverse outcomes.

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 Dentalclean Regenerator Sensitive Dental Gel with Flouride (sodium fluoride 0.24%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dentalclean Regenerator Sensitive Dental Gel with Flouride.
Details

Pediatric Use

Pediatric patients aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. For children aged 2 to 6 years, it is important to instruct them in proper brushing and rinsing habits to minimize the risk of swallowing. Supervision is recommended for children under 6 years, and a pea-sized amount of toothpaste should be used until the child is capable of brushing without supervision.

For children under 2 years of age, the product should not be used unless specifically directed by a dentist or doctor. Additionally, it is crucial to keep the product out of reach of children under 6 years of age to ensure safety.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific warnings, precautions, or dosage modifications regarding the use of Dentalclean Regenerator Sensitive Dental Gel with Fluoride during pregnancy. The available data does not indicate whether the product is contraindicated in pregnancy or presents any risk to the fetus. Healthcare professionals should consider the absence of documented risks while weighing the benefits and potential risks when recommending this product to pregnant patients.

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, immediate medical assistance is crucial. If an individual accidentally swallows an amount exceeding that which is 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 may be necessary, although specific symptoms related to overdosage are not detailed in the available data.

Management of overdosage should follow established protocols, including supportive care and symptomatic treatment as required. It is essential to provide the patient with appropriate medical evaluation and intervention based on the severity of the situation.

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 understanding of the compound's potential effects in these areas.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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 configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product in a dry, cool place, ensuring that it is protected from direct sunlight to maintain its integrity and efficacy. Proper storage conditions are vital for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dentalclean Regenerator Sensitive Dental Gel with Flouride, 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 Regenerator Sensitive Dental Gel with Flouride, 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.