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Dentalclean Dental Gel Booster Adult Use

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Active ingredient
Sodium Fluoride 2.4 mg/1 g
Other brand names
Dosage form
Gel, 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
Gel, 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
84035-006

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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 support your oral health and reduce the risk of developing cavities, contributing to a healthier smile. It's a simple step you can take to maintain your dental hygiene and overall well-being.

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.

It's important to note that this product does not have any known harmful effects on developing babies (teratogenic effects) or any other non-harmful effects. This makes it a safe option for most users looking to maintain their oral 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 old, you should only use this toothpaste if a dentist or doctor specifically advises it. 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 about abuse, misuse, or dependence associated with this medication, always prioritize safety by following this guideline. If you have any questions or concerns about using this medication, consult your healthcare provider for personalized advice.

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. If you have any concerns about side effects or reactions, don’t hesitate to reach out to your healthcare provider for guidance.

Warnings and Precautions

If you accidentally swallow more of this product than intended for brushing your teeth, 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. Acting quickly can help ensure your safety.

Signs of an overdose may not always be obvious, so it's crucial to be vigilant. If you notice any unusual symptoms after swallowing too much, don’t hesitate to reach out for assistance. Remember, it’s always better to be safe and get help if you’re unsure.

Pregnancy Use

While the information provided does not specify any particular safety concerns or precautions for use during pregnancy, it is important to approach any medication with care. There are no dosage modifications recommended for pregnant individuals, which suggests that the standard dosing may be considered safe. However, always consult with your healthcare provider before starting or continuing any medication during pregnancy to ensure it is appropriate for your specific situation. Your health and the health of your baby are the top priority, so open communication with your doctor is essential.

Lactation Use

When it comes to breastfeeding, there is currently no specific information available regarding the use of this medication for nursing mothers or its effects during lactation (the period of breastfeeding). This means that if you are breastfeeding, it’s important to consult with your healthcare provider to discuss any potential risks or considerations related to your specific situation. Always prioritize your health and the well-being of your baby when making decisions about medication use while nursing.

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

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 best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor or pharmacist.

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 for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 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 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?

No specific information regarding the use of this drug during pregnancy is provided.

How should this drug be stored?

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

Are there any specific warnings for this drug?

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

Packaging Info

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

Packaging configurations for Dentalclean Dental Gel Booster Adult Use.
Details

Drug Information (PDF)

This file contains official product information for Dentalclean Dental Gel Booster Adult Use, 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 should use 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 of the situation.

It is crucial to educate patients on the importance of adhering to the recommended usage guidelines to prevent potential adverse effects associated with excessive consumption. Regular monitoring and patient education can help mitigate risks and ensure safe use of the 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 ingesting excessive amounts of the product, underscoring the importance of adhering to the recommended usage guidelines to prevent adverse outcomes.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Dentalclean Dental Gel Booster Adult Use.
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 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 specifically 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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

The use of this medication during pregnancy has not been specifically addressed in the available prescribing information. There are no documented safety concerns related to pregnancy, and no dosage modifications for pregnant individuals are recommended. Additionally, the prescribing information does not outline any special precautions for the use of this medication in pregnant patients. Healthcare professionals should consider the absence of specific data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks.

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. Further research may be necessary to fully understand the implications for breastfed infants.

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, it is critical to seek immediate medical assistance or contact a poison control center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information available when contacting medical professionals or poison control for guidance.

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 ensures optimal preservation of its integrity. It is essential to store the product in a dry, cool environment, away from direct sunlight, to maintain its efficacy and safety. Proper storage conditions are critical to prevent degradation and ensure the product remains effective for its intended use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dentalclean Dental Gel Booster Adult Use, 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 Dental Gel Booster Adult Use, 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.