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Professional Whitening System Whitening Mouth Wash

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This product has been discontinued

Active ingredient
Sodium Fluoride .2 mg/1 mL
Other brand names
Dosage form
Mouthwash
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
February 14, 2014
Active ingredient
Sodium Fluoride .2 mg/1 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 2014
Label revision date
February 14, 2014
Manufacturer
AKG Innovations LLC
Registration number
part355
NDC root
62111-0212

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Drug Overview

This refreshing, mint-flavored mouthwash is specially formulated to help you achieve a healthier-looking, whiter smile. It contains hydrogen peroxide, which aids in whitening your teeth, and sodium fluoride (0.02%), which helps prevent dental cavities. Additionally, menthol provides a cooling sensation, while Salvadora persica, known as nature’s toothbrush, contributes to your oral hygiene.

When used alongside regular brushing and flossing, this mouthwash can promote good oral health and enhance your smile. It's a part of the Dr. Glosman Dental Beauty line, designed to support your dental care routine effectively.

Uses

You can use this product to help prevent dental cavities, which are holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it safe for use.

Dosage and Administration

To use this mouth rinse effectively, you should do so twice a day after brushing your teeth with toothpaste. Measure out 10 ml (which is about 2 teaspoonfuls) of the rinse and swish it vigorously between your teeth for one minute before spitting it out. It's important not to swallow the rinse.

After using the mouth rinse, avoid eating or drinking anything for 30 minutes to allow the rinse to work properly. If you're supervising a child using this rinse, make sure to assist them until they can use it safely on their own. For children under 12 years old, it's best to consult a dentist or doctor before use.

What to Avoid

It's important to be aware of certain situations where you should not use this medication. Specifically, you should avoid using it if you experience oral irritation or tooth sensitivity. These conditions can indicate that the product is not suitable for you at that time.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always prioritize your health and consult with a healthcare professional if you have any questions or concerns about using this medication. Your safety is the most important consideration.

Side Effects

If you experience oral irritation or tooth sensitivity while using this product, it's important to stop using it and consult your dentist. Additionally, keep this product out of reach of children. If a child accidentally swallows more than the recommended amount for rinsing, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

If you experience any irritation in your mouth or sensitivity in your teeth while using this product, it's important to stop using it immediately and consult your dentist. Additionally, keep this product out of reach of children to ensure their safety.

In the event that you accidentally swallow more than the recommended amount for rinsing, seek emergency medical help or contact a Poison Control Center right away. There are no specific laboratory tests required for monitoring while using this product.

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

While the information provided does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to consult with your healthcare provider before taking any medication during pregnancy. They can offer personalized advice based on your health and circumstances.

Since there are no special precautions mentioned regarding use during pregnancy, maintaining open communication with your doctor about any medications you are considering is essential for ensuring the safety of both you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

When it comes to using this product for children, it's important to follow specific guidelines. For adults and children aged 12 and older, you should use it twice daily after brushing your teeth with toothpaste. However, if your child is under 12 years old, it's best to consult a dentist or doctor before use. Additionally, make sure to supervise younger children while they use the product until they are able to do so independently. This ensures their safety and proper use.

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 the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional for personalized advice. They can help determine the best approach to using this medication safely and effectively, considering any unique health needs or conditions.

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 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 change based on liver impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your liver condition, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using this medication.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and proper functioning.

Additional Information

No further information is available.

FAQ

What is the Professional Whitening System Whitening Mouth Wash?

It is a refreshing, mint-flavored mouthwash formulated with Hydrogen Peroxide for a healthier-looking, whiter smile, menthol for a cooling sensation, and Salvadora Persica, known as nature’s toothbrush.

What is the active ingredient in this mouthwash?

The active ingredient is Sodium Fluoride 0.02%, which serves the purpose of anticavity.

How should I use the mouthwash?

Use twice daily after brushing your teeth. Vigorously swish 10 ml (2 teaspoonfuls) for 1 minute and then spit it out. Do not swallow the rinse.

Can children use this mouthwash?

Children under 12 years of age should consult a dentist or doctor before use. Supervise children as necessary until they can use it without supervision.

What should I do if I experience oral irritation or tooth sensitivity?

Stop using the mouthwash and ask a dentist if you experience oral irritation or tooth sensitivity.

Is there any risk if the mouthwash is swallowed?

If more than the recommended amount is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Are there any contraindications for this mouthwash?

No specific contraindications are mentioned for this mouthwash.

Is this mouthwash safe to use during pregnancy or while nursing?

The provided text does not specify any safety concerns or recommendations regarding use during pregnancy or lactation.

How should I store the mouthwash?

Store the mouthwash at room temperature.

Packaging Info

Below are the non-prescription pack sizes of Professional Whitening System Whitening Mouth Wash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Professional Whitening System Whitening Mouth Wash.
Details

Drug Information (PDF)

This file contains official product information for Professional Whitening System Whitening Mouth Wash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

PROFESSIONAL WHITENING SYSTEM WHITENING MOUTH WASH is a dental care product formulated with 0.02% Sodium Fluoride, serving as an anticavity agent. Each 7.4 fl. oz. (220 mL) bottle contains Hydrogen Peroxide, which aids in whitening teeth. The mouthwash features a refreshing mint flavor enhanced by menthol, providing a cooling sensation. Additionally, it includes Salvadora Persica, known for its natural tooth-cleaning properties. This mouthwash is designed to promote good oral hygiene when used in conjunction with regular brushing and flossing twice daily.

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 12 years of age or older should use the rinse twice daily, following brushing with a toothpaste. The recommended method involves vigorously swishing 10 ml (2 teaspoonfuls) of the rinse between the teeth for 1 minute, after which the solution should be expectorated. It is imperative that the rinse is not swallowed.

Patients should refrain from eating or drinking for 30 minutes following the use of the rinse to ensure optimal efficacy. Caregivers are advised to supervise children as necessary until they demonstrate the ability to use the rinse without assistance. For children under 12 years of age, consultation with a dentist or doctor is recommended prior to use.

Contraindications

Use is contraindicated in patients experiencing oral irritation or tooth sensitivity.

Warnings and Precautions

Oral irritation or tooth sensitivity may occur during the use of this product. In such cases, it is imperative to discontinue use immediately and consult a dentist for further evaluation and management.

To ensure safety, this product should be kept out of reach of children. This precaution is essential to prevent accidental ingestion or misuse.

In the event that more than the recommended amount for rinsing is accidentally swallowed, it is crucial to seek emergency medical assistance or contact a Poison Control Center without delay. Prompt action is necessary to address any potential health risks associated with excessive ingestion.

Healthcare professionals are advised to monitor patients for any signs of oral irritation or tooth sensitivity, and to provide appropriate guidance should these symptoms arise.

Side Effects

Patients may experience oral irritation or tooth sensitivity while using this product. In such cases, it is advised to discontinue use and consult a dentist.

Additionally, it is important to keep this product out of reach of children. If a child accidentally swallows more than the amount intended for rinsing, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 Professional Whitening System Whitening Mouth Wash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Professional Whitening System Whitening Mouth Wash.
Details

Pediatric Use

Pediatric patients aged 12 years and older may use the product twice daily after brushing their teeth with a toothpaste. It is important to supervise younger children as necessary until they are capable of using the product without supervision. For children under 12 years of age, consultation with a dentist or doctor is recommended prior to use.

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

Pregnancy

The available data regarding the use of this medication during pregnancy do not indicate specific safety concerns. There are no documented dosage modifications required for pregnant individuals, nor are there any special precautions outlined for use during pregnancy. Healthcare professionals should consider the absence of specific risk data when prescribing this medication to pregnant patients. As with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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 is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

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

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount for rinsing is accidentally swallowed.

Additionally, patients should be instructed to discontinue use and consult a dentist if they experience any oral irritation or tooth sensitivity. It is important for patients to be aware of these potential issues to ensure their safety and well-being while using the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Professional Whitening System Whitening Mouth Wash, 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 Professional Whitening System Whitening Mouth Wash, 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.