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Dentalclean Ultra Refreshing Extreme Ice Dental Gel

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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
March 26, 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
March 26, 2024
Manufacturer
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
Registration number
M021
NDC root
84035-001

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, which can be an important part of maintaining good oral health. By using this product, you can take a proactive step in reducing the risk of cavities and supporting your overall dental hygiene.

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.

Rest assured, this product does not have any known teratogenic effects, meaning it does not cause birth defects. Additionally, there are no reported nonteratogenic effects, so you can feel confident in its safety for general use.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly. You should aim to brush after each meal or at least twice a day. If your dentist or doctor has given you specific instructions, be sure to follow those as well. Regular brushing helps remove food particles and plaque, which can lead to cavities and gum disease if not taken care of. Make this a part of your daily routine for the best oral health!

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

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 minimize any risks.

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 guidance. Your health and well-being are the top priority, so don’t hesitate to reach out for help if needed.

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

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you understand the best options for your health and the health of 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 effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it’s advisable to consult with your healthcare provider to discuss any potential risks or concerns related to your situation. They can help you make informed decisions about your health and your baby's well-being.

Pediatric Use

It's important to keep this product out of reach of children to ensure their safety. If your child accidentally swallows more than the amount used for brushing, seek medical help or contact a poison control center immediately.

When using this product, make sure to brush your child's teeth thoroughly, ideally after each meal or at least twice a day, unless directed otherwise by a dentist or doctor. Following these guidelines will help maintain your child's dental health while keeping them safe.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to help manage your care effectively.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 effectiveness and prevents any potential damage.

When handling the product, always ensure that your hands are clean and dry to avoid contamination. Following these simple storage and handling guidelines will help you use the product safely and effectively.

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.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned.

What should I do if I accidentally swallow more than the recommended amount?

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

How should I use this drug?

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

Are there any contraindications for this drug?

No contraindications are listed.

Is this drug a controlled substance?

No controlled substance classification or details are provided.

What should I know about drug interactions?

No specific drug interactions are mentioned.

How should I store this drug?

Store it in a dry, cool place away from sunlight.

Is there any information regarding use during pregnancy or nursing?

No specific information is provided regarding use during pregnancy or nursing.

What precautions should I take regarding children?

Keep this drug out of reach of children.

Packaging Info

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

Packaging configurations for Dentalclean Ultra Refreshing Extreme Ice Dental Gel.
Details

Drug Information (PDF)

This file contains official product information for Dentalclean Ultra Refreshing Extreme Ice Dental Gel, 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

Healthcare professionals are advised to instruct patients to brush their teeth thoroughly, preferably after each meal or at least twice a day. This regimen should be followed unless otherwise directed by a dentist or physician. Proper brushing technique is essential for maintaining oral hygiene and preventing dental issues.

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

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. Monitoring for any signs of toxicity or adverse reactions is recommended in cases of accidental overdose.

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 identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Ultra Refreshing Extreme Ice Dental Gel (sodium fluoride 0.24%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dentalclean Ultra Refreshing Extreme Ice Dental Gel.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a poison control center is necessary.

For optimal oral hygiene, pediatric patients are directed to brush their teeth thoroughly, preferably after each meal or at least twice a day, or as otherwise directed by a dentist or doctor.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. 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 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 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. The effects on breastfed infants have not been established, and further research may be necessary to determine safety and efficacy in this population.

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 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 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 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 children.

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 Ultra Refreshing Extreme Ice Dental Gel, 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 Ultra Refreshing Extreme Ice Dental Gel, 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.

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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.