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Pcxx Naf Rns Mint

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.5 mg/1 mL
Other brand names
Dosage form
Rinse
Routes
  • Dental
  • Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
November 22, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Sodium Fluoride 0.5 mg/1 mL
Other brand names
Dosage form
Rinse
Routes
  • Dental
  • Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
November 22, 2017
Manufacturer
Ross Healthcare Inc.
Registration number
part355
NDC root
62007-400
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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, making it an important part of maintaining good oral health. By using this product, you can take proactive steps to keep your smile healthy and reduce the risk of tooth decay.

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. Keeping your teeth healthy is essential for maintaining a bright smile and overall well-being.

Dosage and Administration

After you brush your teeth with toothpaste, you can use this mouth rinse once a day. Start by removing the cap from the bottle. Hold the bottle upright and gently squeeze it to fill the rinse to the FILL LINE, which is marked on the bottle. You will pour out exactly 10 milliliters of the rinse, which is the correct dose.

Next, vigorously swish the 10 milliliters of rinse between your teeth for one minute, then spit it out. It's important not to swallow the rinse. After using it, avoid eating or drinking for 30 minutes to allow the rinse to work effectively. If you're helping children under 12, make sure to teach them how to rinse properly to prevent swallowing, and supervise them until they can do it on their own. For children under 6 years old, it's best to consult a dentist or doctor before use.

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 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

It's important to keep this medication out of reach of children. If you accidentally swallow more than what is intended for rinsing, seek medical help or contact the Poison Control Center immediately. This ensures your safety and helps prevent any potential harm.

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 the Poison Control Center.

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 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 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

There is currently no specific information available regarding the use of sodium fluoride rinse during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any medications or treatments you are considering during pregnancy.

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 about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

When using this product for children, it's important to follow specific guidelines to ensure their safety and effectiveness. For children aged 6 years and older, you can use it once a day after brushing their teeth. However, if your child is under 12, make sure to teach them proper rinsing habits to help prevent swallowing the product. It's also a good idea to supervise younger children until they can use it independently.

If your child is under 6 years old, please consult a dentist or doctor before use. This will help ensure that the product is appropriate for their age and needs.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

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

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, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account your unique health needs. Always feel free to ask questions and share any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep the bottle upright. It's important to protect the product from light to maintain its effectiveness. Once you open the bottle, remember to discard it after use to prevent any contamination or degradation. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should use this product topically in your mouth once a day after brushing your teeth. If you have children under 12, make sure to teach them good rinsing habits to avoid swallowing the product, and supervise them until they can use it safely on their own. Always keep the product out of reach of children. If a child accidentally swallows more than the recommended amount, seek medical help or contact the Poison Control Center immediately.

FAQ

What is the purpose of this drug?

This drug aids in the prevention of dental cavities.

How should adults and children 6 years and older use this rinse?

Use once a day after brushing your teeth. Swish 10 milliliters of the rinse between your teeth for 1 minute and then spit it out.

What should I do if a child under 6 years of age needs to use this rinse?

Consult a dentist or doctor before use.

Are there any warnings I should be aware of?

Keep the rinse out of reach of children. If more than the recommended amount is swallowed, seek medical help or contact Poison Control Center immediately.

What should I do after using the rinse?

Do not eat or drink for 30 minutes after rinsing.

How should I store this rinse?

Store at room temperature, keep the bottle upright, and protect it from light. Discard after opening.

Is there any specific information regarding use during pregnancy or nursing?

There are no specific warnings or recommendations regarding use during pregnancy or nursing in the provided text.

What should I do if I accidentally swallow the rinse?

Get medical help or contact Poison Control Center right away.

Packaging Info

Below are the non-prescription pack sizes of Pcxx Naf Rns Mint (sodium fluoirde). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pcxx Naf Rns Mint.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Sodium Fluoride is a white, odorless, crystalline powder. It is characterized by its chemical stability and is utilized in various applications, particularly in dental care. No inactive ingredients are specified in the provided information.

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 product once daily, following brushing with toothpaste. To administer, the cap should be removed, and the bottle held upright while squeezing to fill the container to the designated FILL LINE. The user should then pour out the solution, which will dispense the correct dose of 10 milliliters.

The 10 milliliters of rinse should be vigorously swished between the teeth for a duration of 1 minute before spitting it out. It is imperative that the rinse is not swallowed. Following the rinsing procedure, individuals should refrain from eating or drinking for 30 minutes to ensure optimal effectiveness.

For children under 12 years of age, it is essential to instruct them 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

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

It is imperative to keep this product out of 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 the 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 for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Pcxx Naf Rns Mint (sodium fluoirde). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pcxx Naf Rns Mint.
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 instruct children under 12 years of age in proper rinsing techniques to minimize the risk of swallowing. Supervision is recommended for children until they are capable of using the product without assistance. For children under 6 years of age, consultation with a dentist or doctor is advised 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There is no specific information regarding the use of sodium fluoride rinse during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential benefits and risks be carefully weighed before prescribing this medication to pregnant individuals.

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 about 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 this medication. Consequently, there are no established 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. 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 the 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 related to the specific substance involved is essential, as these may vary based on the nature of the overdosage.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate supportive care measures. It is advisable to follow established protocols for the management of overdoses, which may involve symptomatic treatment and monitoring of vital signs.

In summary, swift action and adherence to recommended guidelines are critical in the management of overdosage situations to ensure patient safety and optimal outcomes.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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 for patients to understand the potential risks associated with improper access to the medication by young individuals. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied in a bottle that must be stored at room temperature. It is essential to keep the bottle in an upright position to maintain its integrity. Additionally, the product should be protected from light exposure to ensure its efficacy. Once opened, the product must be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The product is administered topically and dentally, with a recommended frequency of once daily after brushing teeth with toothpaste. Clinicians should instruct patients, particularly children under 12 years of age, on proper rinsing techniques to minimize swallowing. It is essential to supervise children until they are capable of using the product without assistance. Additionally, the product should be kept out of reach of children. In the event of accidental ingestion beyond the recommended rinsing amount, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Pcxx Naf Rns 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 Pcxx Naf Rns 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.

Learn more in our Editorial Policy

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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.