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Pro Care Flouride

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This product has been discontinued

Active ingredient
Sodium Fluoride 2.1 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
August 10, 2020
Active ingredient
Sodium Fluoride 2.1 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
August 10, 2020
Manufacturer
DILIGO HOLDINGS JOINT STOCK COMPANY
Registration number
part355
NDC root
78989-001

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If you are a consumer or patient please visit this version.

Drug Overview

This drug is designed to help prevent dental cavities, which are small holes in your teeth caused by decay. By using this medication, you can support your oral health and reduce the risk of developing cavities, contributing to a healthier smile.

Uses

You can use this product to help prevent dental cavities. It works by strengthening your teeth and making them more resistant to decay. It's important to maintain good oral hygiene alongside using this product for the best results.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. This makes it a safe option for most users.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly, ideally after each meal or at least twice a day. If you're an adult or a child aged 2 years and older, make sure to follow this routine or any specific instructions given by your dentist or doctor.

For children under 6 years old, it's essential to teach them proper brushing and rinsing techniques to help prevent swallowing toothpaste. You should supervise them while they brush until they are able to do it on their own safely. If your child is under 2 years old, it's best to consult with a dentist or doctor for guidance on how to care for their teeth.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. If you accidentally swallow more than what is typically used for brushing your teeth, seek medical help or contact a poison control center immediately. This precaution ensures your safety and well-being.

Currently, there are no listed contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. However, always use it as directed to avoid any potential issues.

Side Effects

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 precaution is crucial to ensure your safety and well-being. Always use the product as directed to minimize any risks.

Warnings and Precautions

It's important to keep this product out of reach of children under 6 years old. If a child accidentally swallows more than what is typically used for brushing, you should seek medical help or contact a poison control center immediately.

While there are no specific general precautions or laboratory tests mentioned, always use the product as directed. If you have any concerns or experience unusual symptoms, don't hesitate to reach out to your healthcare provider for guidance.

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 a 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 about your health after swallowing too much, don’t hesitate to reach out for professional assistance. Your well-being is the top priority.

Pregnancy Use

When considering the use of Pro Care Fluoride (sodium fluoride gel) during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the potential risks and benefits of using this product while pregnant have not been clearly established.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication or supplement, including fluoride products. They can provide personalized advice based on your health needs and circumstances.

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 are no particular considerations or precautions mentioned for lactation. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your nursing infant. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. If your child is under 6, make sure to teach them proper brushing and rinsing techniques to help prevent swallowing the product. You should supervise them until they are able to use it safely on their own.

For children under 2 years old, it's best to consult with a dentist or doctor before use. This ensures that you are making the safest choice for your little one’s health.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. If you or a loved one is an older adult, always consult with a healthcare provider before starting a new medication. They can help determine the best approach based on individual health needs and any other medications being taken.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for ensuring safety and effectiveness. They can monitor for any potential side effects and make recommendations tailored to your situation.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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 dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health.

Make sure to keep your doctor informed about your liver condition, as they may want to monitor your liver function regularly to ensure everything is working well. Your health and safety are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

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 drug interactions or laboratory test interactions associated with the medication. 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 any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, it's important to store it properly. Keep it away from direct sunlight for extended periods, as this can affect its effectiveness. After each use, make sure to securely close the cap to maintain its integrity and prevent contamination.

By following these simple steps, you can help ensure that your product remains safe and effective for your needs. Always handle it with care to avoid any potential issues.

Additional Information

You will use this medication through a dental route, which means it is applied in a dental setting. It's important to maintain good oral hygiene, so make sure to brush and rinse your mouth properly to avoid swallowing the medication. If you are supervising children, ensure they are monitored until they can use the product safely on their own.

FAQ

What is the primary use of this drug?

The drug aids in the prevention of dental cavities.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned.

What should I do if more than the recommended amount is swallowed?

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

What are the instructions for children under 6 years old?

Instruct children in good brushing and rinsing habits to minimize swallowing, and supervise them until they can use it without supervision.

What should I do for children under 2 years old?

Consult a dentist or doctor for children under 2 years old.

Are there any contraindications for this drug?

No contraindications are listed.

Is this drug safe for nursing mothers?

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

What precautions should I take when using this drug?

Keep the drug out of reach of children under 6 years of age and avoid swallowing more than the recommended amount.

How should I store this drug?

Keep away from direct sunlight for a long time and close the cap after usage.

Is there any specific information regarding elderly patients?

No specific information regarding geriatric use or safety concerns is provided.

Packaging Info

Below are the non-prescription pack sizes of Pro Care Flouride (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pro Care Flouride.
Details

Drug Information (PDF)

This file contains official product information for Pro Care Flouride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by the SPL Code 34089-3 and is supplied in a bottle.

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 aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children under 6 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children during brushing until they are capable of performing the task independently.

For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if more than the recommended amount for brushing is accidentally swallowed, medical assistance should be sought immediately or contact a poison control center.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to instruct patients to contact a poison control center or seek emergency medical help without delay.

No specific general precautions or laboratory tests have been identified for this product. However, the emphasis on the importance of monitoring for accidental ingestion remains critical in ensuring patient safety.

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

Packaging & NDC

Below are the non-prescription pack sizes of Pro Care Flouride (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pro Care Flouride.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children under 6 years of age. For children under 6 years, it is important to instruct them in good brushing and rinsing habits to minimize swallowing. Supervision is recommended until the child is capable of using the product without assistance.

For children under 2 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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Pro Care Flouride (sodium fluoride gel) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant women, as the potential risks and benefits have not been established. It is advisable to weigh the necessity of treatment against any unknown risks to fetal outcomes. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may consider the use of this product in nursing mothers without special concerns based on the available information.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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 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 warranted based on clinical judgment.

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 and providing appropriate management based on clinical presentation is essential. It is recommended that healthcare providers familiarize themselves with local poison control resources to ensure rapid access to expert guidance in such situations.

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 insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize the potential risks associated with misuse. In the event that more than the recommended amount used for brushing is accidentally swallowed, patients should be instructed to seek medical help or contact a poison control center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

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 location that is shielded from direct sunlight to prevent degradation over time.

After each use, the cap must be securely closed to maintain the product's efficacy and prevent contamination. Proper handling and storage conditions are crucial for ensuring the product remains effective throughout its intended shelf life.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should instruct patients on proper brushing and rinsing techniques to minimize swallowing, and it is important to supervise children until they are capable of using the product without assistance.

Drug Information (PDF)

This file contains official product information for Pro Care Flouride, 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 Pro Care Flouride, 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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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.