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Dentalclean Green 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 2025
Label revision date
July 14, 2025
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 2025
Label revision date
July 14, 2025
Manufacturer
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
Registration number
M021
NDC root
84035-012

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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. By incorporating it into your oral care routine, you can support your dental health and reduce the risk of developing cavities, which are small holes in your teeth caused by decay. Regular use can be an effective way to maintain a healthy smile.

Dosage and Administration

To use this mouth rinse effectively, you should do so twice 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 the rinse into the cap.

Once you have the rinse in the cap, take it and vigorously swish it between your teeth for 30 to 60 seconds. After swishing, make sure to spit it out; do not swallow the rinse. For the best results, avoid eating or drinking anything for 30 minutes after you rinse. This will help ensure that the rinse works effectively to keep your mouth healthy.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the information provided, there are no particular conditions or risks that would prevent you from using it safely. Always remember to consult with your healthcare provider if you have any questions or concerns about your treatment.

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 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

When it comes to using Dentalclean Green Diamond Alcohol Free Mouthwash during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the manufacturer has not provided guidance on how this mouthwash may affect you or your developing baby.

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. They can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

When using this product for children aged 6 years and older, you should apply it twice a day after they brush their teeth with toothpaste. It's important to supervise their use to ensure they follow the instructions correctly. Always keep this product out of reach of younger children to prevent any accidental ingestion or misuse.

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 for patients with 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 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 or tests you may be taking. In this case, there are no known interactions with other drugs or laboratory tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

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 that you are in a sterile field (a clean area free from germs) to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the purpose of this mouthwash?

This mouthwash aids in the prevention of dental cavities.

How should I use the mouthwash?

Use the mouthwash twice a day after brushing your teeth. Swish it between your teeth for 30 to 60 seconds and then spit it out.

What are the instructions for using the mouthwash?

Remove the cap, hold the bottle upright, squeeze to pour the rinse into the cap, swish vigorously between your teeth, and do not swallow.

Are there any warnings I should be aware of?

If more than the amount used for brushing is accidentally swallowed, seek medical help or contact a poison control center immediately.

Is there any information on using this mouthwash during pregnancy or while nursing?

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

How should I store the mouthwash?

Store the mouthwash in a dry, cool place away from sunlight.

Who can use this mouthwash?

This mouthwash is suitable for adults and children aged 6 years and older.

Are there any contraindications for this mouthwash?

No contraindications are listed for this mouthwash.

Packaging Info

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

Packaging configurations for Dentalclean Green Diamond Alcohol Free Mouthwash.
Details

Drug Information (PDF)

This file contains official product information for Dentalclean Green Diamond Alcohol Free Mouthwash, 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. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse twice daily, following the brushing of their teeth with toothpaste.

To administer, the healthcare professional should guide the patient to first remove the cap from the bottle. The bottle should be held upright while gently squeezing to pour the rinse into the cap. The patient should then vigorously swish the rinse between their teeth for a duration of 30 to 60 seconds before spitting it out. It is crucial that the patient does not swallow the rinse. Additionally, patients should refrain from eating or drinking for 30 minutes after rinsing to ensure optimal effectiveness.

Contraindications

There are no contraindications listed for this product. It is deemed safe for use across various patient populations, with no specific conditions or situations identified that would preclude its administration.

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 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

No drug interactions have been identified for the product, indicating that it does not have clinically significant interactions with other medications. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Dentalclean Green Diamond Alcohol Free Mouthwash.
Details

Pediatric Use

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

There is no specific information regarding the use of Dentalclean Green 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 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 have the product's labeling and any relevant patient information available when contacting medical professionals or poison control for further guidance.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged to store the medication in a secure location, such as a locked cabinet or high shelf, to ensure safety.

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 Green 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 Green 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.

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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.