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Dentalclean Whitening Max

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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 2024
Label revision date
May 7, 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 7, 2024
Manufacturer
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
Registration number
M021
NDC root
84035-004

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, contributing to better oral health. While specific details about its mechanism of action are not provided, its primary purpose is to support you in maintaining a cavity-free smile.

Uses

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

It's important to note that this product does not have any known teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects. This makes it a safe option for maintaining your dental hygiene.

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 proper brushing and rinsing techniques 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 of age, 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 abuse, misuse, 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 precaution is crucial to ensure your safety and well-being. Always use the product as directed to avoid any potential risks.

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. This is crucial to ensure your safety and receive the appropriate care.

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 or experience unusual symptoms after swallowing too much, don’t hesitate to reach out for professional assistance. Your health and well-being are the top priority.

Pregnancy Use

When it comes to using Dentalclean Whitening Max (sodium fluoride 0.24% paste, dentifrice) during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best oral care practices during this time. Always prioritize your health and the health of your baby by seeking professional advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to note that there is no specific information available about the use of Dentalclean Whitening Max during lactation. This means that the effects on breast milk or nursing infants have not been studied or documented.

As always, it's a good idea to consult with your healthcare provider before using any new products while breastfeeding to ensure the safety and well-being of both you and your baby.

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 years 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, it’s important to consult with a healthcare provider before starting the medication. 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 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 for your liver health. They can help determine the best approach for your treatment based on your individual circumstances.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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 them 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 you 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?

No specific information regarding pregnancy use or safety concerns is provided.

How should this drug be stored?

Store this drug in a dry, cool place away from sunlight.

Are there any known drug interactions with this drug?

No specific drug interactions are mentioned.

What precautions should be taken for children under 6 years of age?

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

Packaging Info

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

Packaging configurations for Dentalclean Whitening Max.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific information regarding the Description section for SPL code 34089-3 is 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 in this age group as necessary and should use a pea-sized amount of product until the child is capable of brushing without supervision.

The use of this product is not recommended for children under 2 years of age 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 following accidental ingestion is recommended, and appropriate supportive care should be initiated as necessary.

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.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Dentalclean Whitening Max.
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 techniques to minimize the risk of swallowing toothpaste. Supervision is recommended for children under 6 years of age, 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 use of this product is not recommended unless directed by a dentist or doctor. Additionally, it is crucial to keep the product out of reach of children under 6 years 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 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 Dentalclean Whitening Max (sodium fluoride 0.24% paste, dentifrice) in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Therefore, healthcare professionals should exercise caution when recommending this product to pregnant patients, considering the absence of data on potential fetal impacts. Women of childbearing potential should be informed of the lack of available information and encouraged to discuss any concerns with their healthcare provider.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Dentalclean Whitening Max. Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers, as the effects on breastfed infants are not 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 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 related to the specific substance involved is essential, although specific symptoms were not detailed in the provided information.

Management procedures should include supportive care and symptomatic treatment as necessary, guided by the clinical presentation of the patient. It is advisable to follow established protocols for the management of overdosage in accordance with local guidelines and the specific characteristics of the substance involved.

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 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 environment, 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 Whitening Max, 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 Whitening Max, 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.