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Dentalclean Blue Diamond Alcohol Free Mouthwash

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Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Rinse
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
May 15, 2024
Active ingredient
Sodium Fluoride 0.2 mg/1 mL
Other brand names
Dosage form
Rinse
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 15, 2024
Manufacturer
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
Registration number
M021
NDC root
84035-009

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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 an important tool in maintaining good 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 has not been associated with any teratogenic effects (harmful effects on a developing fetus) or nonteratogenic effects (harmful effects that are not related to fetal development). This means it is considered safe in these aspects.

Dosage and Administration

To use this mouth rinse effectively, you should do so once a day after brushing your teeth with toothpaste. Start by removing the cap from the bottle. Hold the bottle upright and gently squeeze it to pour out the rinse into your mouth.

Next, vigorously swish the rinse between your teeth for one minute, making sure to avoid swallowing it. After swishing, spit the rinse out. It's important not to eat or drink anything for 30 minutes after using the rinse to allow it to work effectively. Remember, this rinse is meant for oral use only, so make sure to follow these steps daily for the best results.

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. This precaution helps prevent accidental ingestion, which can be dangerous for young children.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use medications responsibly.

Side Effects

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

There is currently no specific information available about the use of Dentalclean Blue Diamond Alcohol Free Mouthwash during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product insert.

If you are pregnant or planning to become pregnant, it’s always a good idea to consult with your healthcare provider before using any new products, including mouthwash, to ensure they are safe for you and your baby.

Lactation Use

There is no specific information available about the use of Dentalclean Blue Diamond Alcohol Free Mouthwash for nursing mothers or its effects during lactation (the period of breastfeeding). Since the drug insert does not address this topic, it’s important to consult with your healthcare provider if you have any concerns about using this mouthwash while breastfeeding. They can help you understand any potential risks and make the best choice for you and your baby.

Pediatric Use

When using this product, it is important to know that it is suitable for adults and children who are 6 years old and older. You should apply it once a day after brushing your teeth with toothpaste. However, make sure to keep this product out of reach of younger children, specifically those under 6 years of age, 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 for personalized advice. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 monitor your condition and make any necessary adjustments to your treatment plan.

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 main use of this mouthwash?

This mouthwash aids in the prevention of dental cavities.

How should I use this mouthwash?

Use it once a day after brushing your teeth. Swish it between your teeth for 1 minute and then spit it out.

What should I do if I accidentally swallow the mouthwash?

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

Is this mouthwash safe for children?

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

Are there any contraindications for this mouthwash?

No contraindications are listed for this mouthwash.

Can I use this mouthwash during pregnancy?

No specific information regarding use during pregnancy is provided.

Is this mouthwash safe for nursing mothers?

No specific information regarding nursing mothers or lactation considerations is provided.

How should I store this mouthwash?

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

Packaging Info

Below are the non-prescription pack sizes of Dentalclean Blue Diamond Alcohol Free Mouthwash (sodium fluoride 0.05%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dentalclean Blue Diamond Alcohol Free Mouthwash.
Details

Drug Information (PDF)

This file contains official product information for Dentalclean Blue Diamond Alcohol Free Mouthwash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3.

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 6 years and older are instructed to use the product once daily, following the brushing of their teeth with toothpaste. To administer, the cap should be removed, and the bottle held upright while gently squeezing to pour out the appropriate amount of rinse. The user should then vigorously swish the rinse between their teeth for a duration of 1 minute before spitting it out. It is imperative that the rinse is not swallowed. Additionally, patients should refrain from eating or drinking for 30 minutes following the rinsing to ensure optimal effectiveness.

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.

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 imperative 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 essential in such cases.

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 quantities 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 recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dentalclean Blue Diamond Alcohol Free Mouthwash (sodium fluoride 0.05%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dentalclean Blue Diamond Alcohol Free Mouthwash.
Details

Pediatric Use

Pediatric patients aged 6 years and older may use the product once daily after brushing their teeth with toothpaste. It is important to keep the product out of reach of children under 6 years of age to ensure safety.

Geriatric Use

There is no specific information available 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 Dentalclean Blue Diamond Alcohol Free Mouthwash in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Dentalclean Blue Diamond Alcohol Free Mouthwash. Therefore, the effects on breastfed infants and the excretion of the product in breast milk remain unknown. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this product to lactating mothers.

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 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 Blue Diamond Alcohol Free Mouthwash, 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 Blue Diamond Alcohol Free Mouthwash, 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.