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Fluoride Mouthwash Soft Mint

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.05 g/100 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
August 3, 2020
Active ingredient
Sodium Fluoride 0.05 g/100 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
August 3, 2020
Manufacturer
Swiss Shine Beauty AG
Registration number
part356
NDC root
79763-002

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Drug Overview

vVARDIS is a fluoride mouthwash designed to help maintain oral health by providing fresh breath and protecting your teeth. It is formulated to promote pure whitening and comes in a soft mint flavor, making it a pleasant addition to your daily dental care routine. This mouthwash is produced in Switzerland and is available in a 3.4 fl oz (100 ml) bottle.

The fluoride in vVARDIS works to strengthen tooth enamel and prevent cavities, contributing to overall dental hygiene. Remember, it’s important to use the mouthwash as directed and not to swallow it.

Uses

When using this rinse, it's important to remember that you should not swallow it. This product is designed for topical use only, meaning it should be applied to the affected area rather than ingested.

Additionally, there are no known teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this rinse. Always follow the instructions provided to ensure safe and effective use.

Dosage and Administration

Before using the mouth rinse, make sure to shake the bottle well. If you are an adult or a child aged 6 years and older, you should use the rinse once a day after brushing your teeth with toothpaste. To use it, measure out 10 milliliters of the rinse, swish it vigorously between your teeth for 1 minute, and then spit it out. Remember, do not swallow the rinse.

After using the mouth rinse, it's important not to eat or drink anything for 30 minutes to allow the rinse to work effectively. If you are supervising a child under 12, make sure to teach them good rinsing habits to help prevent swallowing the rinse. For children under 6 years old, it's best to consult a dentist or doctor before use.

What to Avoid

It's important to be aware of certain precautions when using this product. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should take care not to swallow more than what is intended for rinsing. If you accidentally swallow a larger amount, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so please use the product as directed.

Side Effects

It's important to be aware of potential side effects when using this medication. Some common adverse reactions may occur, and while they can vary in severity, it's crucial to monitor how you feel. If you accidentally swallow more than intended, seek medical help or contact a Poison Control Center immediately.

Additionally, keep this medication out of reach of children to prevent any accidental ingestion. Always prioritize safety and consult with a healthcare professional if you have any concerns about side effects or reactions.

Warnings and Precautions

It's important to keep this product out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows more than what is intended for rinsing, seek medical help immediately or contact a Poison Control Center.

Always use this product as directed, and if you experience any unusual symptoms or reactions, stop using it and call your doctor for further advice. Your safety is a priority, so please take these precautions seriously.

Overdose

If you accidentally swallow more of the product than intended for rinsing, it’s important to seek medical help immediately or contact a 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 Fluoride Mouthwash Soft Mint during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that the effects of this mouthwash on you or your developing baby are not well understood.

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 weigh the potential benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you have a child aged 6 years or older, they can use this mouth rinse once a day after brushing their teeth. To use it, they should swish 10 milliliters of the rinse vigorously between their teeth for 1 minute and then spit it out—it's important that they do not swallow the rinse. For children under 12, make sure to teach them good rinsing habits to help prevent swallowing the rinse, and supervise them as needed until they can use it on their own.

If your child is under 6 years old, it's best to consult with a dentist or doctor before using this mouth rinse.

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 that may be present.

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 ensure safe and effective care.

Renal Impairment

If you have kidney issues, 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 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 your product remains safe and effective, always check the safety seal before use. If the seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Proper handling is crucial for your safety, so make sure to follow these guidelines closely.

When storing the product, keep it in a cool, dry place to maintain its integrity. Always handle it with clean hands or gloves to avoid contamination. If you have any questions about disposal or further safety measures, consult the product information or your healthcare provider.

Additional Information

No further information is available.

FAQ

What is vVARDIS?

vVARDIS is a fluoride mouthwash that provides fresh protection and pure whitening, available in a soft mint flavor.

How should I use vVARDIS?

Shake well before use. Adults and children 6 years and older should use it once a day after brushing teeth, swishing 10 milliliters for 1 minute before spitting it out.

Can I swallow vVARDIS?

No, you should not swallow the rinse. If more than the recommended amount is accidentally swallowed, seek medical help immediately.

What should I do after using vVARDIS?

Do not eat or drink for 30 minutes after rinsing to ensure maximum effectiveness.

Is vVARDIS safe for children?

Children under 12 should be instructed in good rinsing habits to minimize swallowing, and those under 6 should consult a dentist or doctor.

Are there any contraindications for vVARDIS?

No specific contraindications are listed for vVARDIS.

Is there any information about vVARDIS use during pregnancy?

The insert does not provide information regarding the use of vVARDIS during pregnancy.

What should I do if I accidentally swallow vVARDIS?

If more than the recommended amount is swallowed, get medical help or contact a Poison Control Center right away.

Is there any information about vVARDIS use while nursing?

There are no specific warnings or recommendations regarding the use of vVARDIS by nursing mothers.

What precautions should I take with vVARDIS?

Keep vVARDIS out of reach of children and do not use it if the safety seal is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Fluoride Mouthwash Soft Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fluoride Mouthwash Soft Mint.
Details

Drug Information (PDF)

This file contains official product information for Fluoride Mouthwash Soft Mint, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

vVARDIS is a fluoride mouthwash formulated to provide fresh breath and protective benefits. It is designed for oral hygiene and features a soft mint flavor. The product is packaged in a 3.4 fluid ounce (100 ml) container. Manufactured in Weissbad, Switzerland, vVARDIS emphasizes pure whitening properties as part of its formulation.

Uses and Indications

This drug is indicated for use as a rinse. It is important to note that the rinse should not be swallowed.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

The product should be shaken well before use. For adults and children aged 6 years and older, the recommended dosage is to use the rinse once daily, following brushing with toothpaste.

To administer, patients should vigorously swish 10 milliliters of the rinse between their teeth for a duration of 1 minute, then spit it out. It is imperative that the rinse is not swallowed. After rinsing, patients should refrain from eating or drinking for 30 minutes to ensure optimal effectiveness.

Healthcare professionals are advised to instruct children under 12 years of age in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be necessary until the child is capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use.

Contraindications

Use of this product is contraindicated in the event of accidental ingestion beyond the recommended rinsing amount. In such cases, immediate medical assistance or contact with a Poison Control Center is advised. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this product out of the reach of children to prevent accidental ingestion. In the event that more than the recommended amount used for rinsing is accidentally swallowed, 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.

Side Effects

Patients should be advised to keep the product out of reach of children. In the event that more than the recommended amount used for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

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 Fluoride Mouthwash Soft Mint (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fluoride Mouthwash Soft Mint.
Details

Pediatric Use

Pediatric patients aged 6 years and older may use the rinse once daily after brushing their teeth with toothpaste. The recommended administration involves vigorously swishing 10 milliliters of the rinse between the teeth for 1 minute before spitting it out; swallowing the rinse is contraindicated.

For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing. Supervision is advised until the child is capable of using the rinse independently.

For children under 6 years of age, consultation with a dentist or doctor is recommended prior to use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no information available regarding the use of Fluoride Mouthwash Soft Mint during pregnancy, including safety concerns, dosage modifications, or any special precautions. Healthcare professionals should consider this lack of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential risks and benefits be carefully weighed before prescribing this product to pregnant individuals.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information 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 intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

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

Serious side effects associated with the use of the product may be reported to Swiss Shine Beauty, Inc., located at 651 N. Broad St., Middletown, DE 19709. Reports may be submitted voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if a patient accidentally swallows more than the recommended amount used for rinsing, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing potential adverse effects associated with misuse.

Storage and Handling

The product is supplied in a tamper-evident container. Healthcare professionals are advised not to use the product if the safety seal is broken or missing.

For optimal storage, it is recommended to keep the product in a controlled environment, ensuring that it is stored at the appropriate temperature range as specified in the product guidelines. Special handling precautions should be observed to maintain the integrity 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 Fluoride Mouthwash Soft Mint, 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 Fluoride Mouthwash Soft Mint, 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.