ADD CONDITION

items per page

Dentalclean Regenerator Sensitive Kids

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 8, 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 8, 2024
Manufacturer
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
Registration number
M021
NDC root
84035-005

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 medication is designed to help prevent dental cavities, which are small holes in your teeth caused by decay. By using this product, you can take an important step towards maintaining your oral health and keeping your teeth strong. It's a simple way to support your dental hygiene routine and reduce the risk of cavities forming.

Uses

You can use this product to help prevent dental cavities, which are 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.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for those looking to protect their dental health.

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. Always supervise young children while brushing and use only a pea-sized amount of toothpaste until they can brush on their own.

For children under 2 years old, you should not use this toothpaste unless a dentist or doctor specifically advises 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 out of reach of children, especially those under 6 years of age. While there are no specific contraindications or concerns regarding controlled substances, abuse, or dependence associated with this medication, always prioritize safety by following the guidelines provided. If you have any questions or concerns about its use, consult with a healthcare professional for guidance.

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 minimize any risks associated with misuse. Your safety is a priority, so be aware of the proper usage guidelines.

Warnings and Precautions

If you accidentally swallow more of this product than intended for brushing your teeth, it’s important to seek medical help immediately or contact your local poison control center.

To ensure your safety, always use the product as directed and keep it out of reach of children. If you experience any unusual symptoms or reactions, stop using the product and call your doctor for further advice.

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. Acting quickly can help ensure your safety.

Signs of an overdose may not always be obvious, so it's best to err on the side of caution. If you have any concerns about your health after swallowing too much, don’t hesitate to reach out for professional assistance. Your well-being is the priority.

Pregnancy Use

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

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can pass into your breast milk, so caution is advised. Since the effects on your nursing infant have not been thoroughly studied, be sure to keep an eye out for any unusual reactions in your baby after using the product. Your health and your baby's well-being are the top priorities, so staying informed and vigilant is key.

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 younger than 6 to ensure their safety.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 is safe and effective, especially if you have any concerns about your kidney health.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving 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, make sure to keep it in a sterile environment (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

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 product?

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 product?

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 product safe for children under 2 years of age?

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

What should you do if more than the recommended amount is 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.

What precautions should nursing mothers take?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

How should this product be stored?

Store in a dry, cool place away from sunlight.

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

No specific information regarding safety concerns or precautions during pregnancy is provided.

What should you do if you have questions about using this product?

Consult a healthcare professional for guidance, especially if you have specific health concerns.

Packaging Info

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

Packaging configurations for Dentalclean Regenerator Sensitive Kids.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific details regarding the Description section for SPL code 34089-3 are provided in the text.

Uses and Indications

This drug is indicated for the prevention of dental cavities.

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

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 in this age group as necessary and recommend the use of a pea-sized amount of product 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 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 that an excessive amount, beyond what is typically used for brushing, is accidentally ingested, it is imperative to seek immediate medical assistance or contact a poison control center. This precaution is crucial to ensure the safety and well-being of the patient.

Healthcare professionals are advised to educate patients on the proper usage of the product to minimize the risk of accidental ingestion. Regular monitoring and patient education can significantly contribute to the safe use of this product.

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 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 Kids (sodium fluoride 0.24%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dentalclean Regenerator Sensitive Kids.
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 daily, 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 techniques to minimize the risk of swallowing. Supervision is recommended for children under 6 years, and a pea-sized amount of product 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 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 and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; it is recommended to monitor for any adverse reactions in the infant.

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 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 of the potential risks associated with overdosage and the importance of prompt intervention. Symptoms of overdosage may vary, and monitoring the patient closely for any adverse effects is recommended.

Management of overdosage should include supportive care and symptomatic treatment as necessary. It is essential to provide the patient with appropriate medical evaluation and intervention based on the severity of the symptoms presented.

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

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 should be referenced for accurate identification. It is essential to store the product in a dry, cool environment, ensuring that it is protected from direct sunlight to maintain its integrity and efficacy. Proper storage conditions are crucial 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 Kids, 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 Kids, 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.