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Cleanafnaturalanticavitytoothpaste

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This product has been discontinued

Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2017
Label revision date
July 14, 2017
Active ingredient
Sodium Fluoride 0.22 g/100 g
Other brand names
Dosage form
Paste
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2017
Label revision date
July 14, 2017
Manufacturer
CLEANAF GLOBAL LIMITED LIABILITY COMPANY
Registration number
part355
NDC root
71603-1700

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Drug Overview

Sodium fluoride is a type of toothpaste designed to help prevent cavities. It contains 0.22% sodium fluoride, which works by strengthening tooth enamel and making it more resistant to decay. This anticavity action is essential for maintaining good oral health and preventing dental issues.

In addition to sodium fluoride, the toothpaste includes several inactive ingredients that contribute to its texture and flavor, such as hydrated silica and sodium lauryl sulfate. Using this toothpaste regularly can be an effective part of your dental care routine to keep your teeth healthy and strong.

Uses

You can use this product to help prevent cavities in your teeth. It works by strengthening your enamel, which is the protective outer layer of your teeth. Keeping your enamel healthy is important for maintaining good oral hygiene and preventing dental issues.

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

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how to take it, or how often to use it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized advice based on your health needs.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of 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 be aware that there are no specific side effects or adverse reactions listed for this medication. However, a key warning to keep in mind is that you should not swallow the medication. If you have any concerns or experience unusual symptoms while using it, please consult your healthcare provider for guidance.

Warnings and Precautions

It’s important to remember that you should not swallow this medication. If you accidentally do, seek medical attention immediately.

While there are no specific general precautions or laboratory tests mentioned, always stay alert to how your body responds to any medication. If you experience any unusual symptoms or reactions, stop taking the medication and contact your doctor right away for guidance. Your health and safety are the top priority.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

There is currently no specific information available about the use of CLEANAF Natural Anticavity Toothpaste during pregnancy. This means that the drug insert does not provide details on safety concerns, dosage adjustments, or any special precautions you should take if you are pregnant or planning to become pregnant.

If you have any concerns about using this toothpaste while pregnant, it’s a good idea to consult with your healthcare provider for personalized advice. They can help you make informed decisions based on your individual health needs.

Lactation Use

When breastfeeding, it's important to be aware of how medications can affect you and your baby. While the specific information about nursing mothers and lactation isn't detailed here, it's always best to consult with your healthcare provider about any medications you are considering. They can help you understand any potential risks and ensure that both you and your baby remain healthy during this time.

If you have concerns about how a particular medication might impact your milk production or your nursing infant, don't hesitate to ask your doctor or a lactation consultant for guidance. Your health and your baby's well-being are the top priorities.

Pediatric Use

When giving this medication to children, it's important to ensure they do not swallow it. This means you should supervise them closely during use to prevent any accidental swallowing, which could lead to complications. Always follow the specific instructions provided for administering the medication to ensure safety and effectiveness. If you have any concerns or questions about how to use it properly, don't hesitate to reach out to your healthcare provider for guidance.

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, 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.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your renal function tests to ensure your kidneys are working properly. If your creatinine clearance (a measure of kidney function) falls below a certain level, a reduced dose may be necessary to avoid potential complications. Additionally, if you have severe renal impairment, special monitoring will be required to keep track of your health and medication effects. Always discuss any concerns with your healthcare provider to ensure your treatment is safe and effective.

Hepatic Impairment

If you have liver problems, it's important to use this medication with caution. Depending on the severity of your liver condition, you may need to adjust your dosage. For those with moderate to severe liver impairment, a reduced dose might be necessary to ensure your safety.

Additionally, if you have a pre-existing liver condition, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) periodically. This helps to ensure that the medication is not causing any harm to your liver. Always discuss any concerns with your doctor to find the best approach for your health.

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 and share any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. Avoid freezing, as this can damage the device. When you're not using the tube, make sure to keep it tightly closed to maintain its integrity and safety. Following these simple guidelines will help you use the product effectively and safely.

Additional Information

No further information is available.

FAQ

What is Sodium Fluoride used for?

Sodium Fluoride is used as an anticavity agent in toothpaste.

What are the inactive ingredients in Sodium Fluoride toothpaste?

Inactive ingredients include hydrated silica, sodium benzoate, sodium lauryl sulfate, water, flavor, sorbitol, CMC, xanthan gum, sodium phytate, sodium saccharin, titanium dioxide, and glycerin.

Is there a warning associated with Sodium Fluoride toothpaste?

Yes, you should not swallow Sodium Fluoride toothpaste.

Are there any teratogenic effects associated with Sodium Fluoride?

No teratogenic effects are mentioned for Sodium Fluoride.

What should I do if I have renal impairment and use Sodium Fluoride?

If you have renal impairment, dosage adjustments may be necessary, and renal function tests should be monitored.

Can Sodium Fluoride be used in patients with hepatic impairment?

Yes, but it should be used with caution, and dosage adjustments may be necessary for those with moderate to severe hepatic impairment.

How should Sodium Fluoride toothpaste be stored?

Store Sodium Fluoride toothpaste at room temperature, do not freeze, and keep the tube tightly closed when not in use.

Packaging Info

Below are the non-prescription pack sizes of Cleanafnaturalanticavitytoothpaste (sodium fluroide paste, dentrifice). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cleanafnaturalanticavitytoothpaste.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Sodium Fluoride 0.22% is a dental product containing 0.10% w/v fluoride ion, formulated to provide effective fluoride therapy. The formulation includes several inactive ingredients: hydrated silica, sodium benzoate, sodium lauryl sulfate, water, flavor, sorbitol, carboxymethyl cellulose (CMC), xanthan gum, sodium phytate, sodium saccharin, titanium dioxide, and glycerin. This combination of components contributes to the product's stability, texture, and palatability, ensuring optimal performance in dental applications.

Uses and Indications

This drug is indicated for the prevention of dental caries (anticavity).

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

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

The product is contraindicated for oral ingestion; it must not be swallowed.

Healthcare professionals should remain vigilant regarding the absence of specific general precautions and laboratory test recommendations associated with this product. It is essential to monitor patients closely for any adverse reactions or complications that may arise during treatment.

In the event of a medical emergency, immediate medical assistance should be sought. Additionally, if any concerning symptoms or side effects occur, patients are advised to discontinue use and consult their healthcare provider promptly.

Side Effects

Patients should be advised that the product should not be swallowed. No specific side effects or adverse reactions have been reported in clinical trials or postmarketing experiences.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Cleanafnaturalanticavitytoothpaste (sodium fluroide paste, dentrifice). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cleanafnaturalanticavitytoothpaste.
Details

Pediatric Use

Pediatric patients should be advised not to swallow the medication. It is important for healthcare professionals to ensure that children understand this instruction to prevent potential complications associated with improper 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 CLEANAF Natural Anticavity Toothpaste during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise clinical judgment when recommending this product to women of childbearing potential. It is advisable to consider the overall health and needs of the patient when discussing oral care products during pregnancy.

Lactation

There is no specific information available regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers. It is advisable to consider the potential risks and benefits of treatment in the context of breastfeeding.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these patients regularly. For individuals with a creatinine clearance below a specified threshold, a reduced dose should be considered. Additionally, special monitoring may be necessary for patients with severe renal impairment to mitigate potential risks associated with their condition.

Hepatic Impairment

Use of the medication in patients with hepatic impairment requires caution. For patients with moderate to severe hepatic impairment, dosage adjustments may be necessary to ensure safety and efficacy. It is recommended that liver function tests be monitored periodically in patients with pre-existing liver conditions to assess their liver function status. In cases of significant liver dysfunction, consideration should be given to reducing the dose to mitigate potential risks associated with impaired liver function.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the substance involved, the estimated dose, and the time of ingestion, is crucial for effective treatment and follow-up care.

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 medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of safeguarding the medication to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, avoiding exposure to freezing conditions. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Cleanafnaturalanticavitytoothpaste, 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 Cleanafnaturalanticavitytoothpaste, 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

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.