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Farmasi Whitening

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Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
November 5, 2023
Active ingredient
Sodium Fluoride 1.5 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Dental
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2021
Label revision date
November 5, 2023
Manufacturer
Farmasi US LLC
Registration number
M021
NDC root
74690-012

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

Drug Overview

This product is designed to help protect your teeth and prevent cavities. It also works to whiten your teeth by removing surface stains, giving you a brighter smile. By using this product regularly, you can maintain better oral health and enhance the appearance of your teeth.

Uses

Taking care of your teeth is essential, and one way to do that is by using products that help protect them and prevent cavities. These products can create a barrier that keeps harmful bacteria at bay, ensuring your smile stays healthy.

In addition to protection, many of these products also work to whiten your teeth. They achieve this by removing surface stains, giving you a brighter, more confident smile. So, not only are you safeguarding your dental health, but you're also enhancing the appearance of your teeth.

Dosage and Administration

To keep your teeth healthy, it's important to brush them thoroughly after meals. You should aim to brush at least twice a day, or follow any specific instructions given by your dentist or physician. This routine helps remove food particles and plaque, which can lead to cavities and gum disease if not addressed.

If you have children aged 6 years or older, the same brushing guidelines apply to them as well. Establishing a consistent brushing habit early on can set the foundation for a lifetime of good oral health.

What to Avoid

It's important to be aware of certain guidelines when using this product. You should not use it in children under 6 years of age. If more than the recommended amount for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always use it as directed to ensure safety and effectiveness.

Side Effects

It's important to keep this product out of reach of children, especially those under 6 years old. If a child accidentally swallows more than what is typically used for brushing their teeth, seek medical help or contact a Poison Control Center immediately.

Always be cautious and ensure that this product is used safely to prevent any potential harm.

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 immediately or contact a Poison Control Center.

While there are no specific general precautions or laboratory tests mentioned, always use the product as directed to ensure safety. 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 be obvious, 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 Farmasi Whitening Toothpaste (sodium fluoride paste, dentifrice) during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the manufacturer has not provided guidance on how this product may affect you or your baby during pregnancy.

If you are pregnant or planning to become pregnant, it's always a good idea to consult with your healthcare provider before using any new products, including toothpaste. They can help you make informed decisions based on your individual health needs.

Lactation Use

While the drug insert for Farmasi Whitening Toothpaste does not provide specific information about nursing mothers or considerations for breastfeeding, it's always a good idea to be cautious. If you are breastfeeding, you may want to consult with your healthcare provider before using any new products, including toothpaste, to ensure they are safe for you and your baby.

Remember, your health and your baby's well-being are important, so don't hesitate to ask questions or seek guidance from a medical professional.

Pediatric Use

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, seek medical help or contact a Poison Control Center immediately.

For children aged 6 years and older, you should encourage them to brush their teeth thoroughly after meals or at least twice a day, unless directed otherwise by a dentist or physician. This helps maintain good oral hygiene and overall dental health.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 health situation with your healthcare provider, as they can offer personalized advice 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 tests to ensure your liver is functioning well while you are on any 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 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 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 and avoid freezing it, as extreme temperatures can affect its effectiveness. When not in use, make sure to keep the tube tightly closed to maintain its integrity. If you open the product but do not use it within a specified time frame, be sure to discard it to ensure safety and effectiveness.

Additional Information

You should use this product by applying it through a dental route, which means it is intended for use in your mouth. For adults and children aged 6 years and older, it is recommended to brush your teeth thoroughly at least twice a day after meals, or as directed by your dentist or physician. Following these guidelines will help ensure effective use of the product.

FAQ

What is the purpose of this toothpaste?

This toothpaste helps protect teeth and prevents cavities while also whitening teeth by removing surface stains.

Who can use this toothpaste?

Adults and children 6 years of age and older can use this toothpaste.

How should I use this toothpaste?

You should brush your teeth thoroughly after meals or at least twice a day, or as directed by a dentist or physician.

Are there any age restrictions for using this toothpaste?

Yes, do not use this toothpaste in children under 6 years of age.

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.

How should I store this toothpaste?

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

Is there any information regarding use during pregnancy or nursing?

No specific information regarding use during pregnancy or nursing is provided in the drug insert.

Are there any contraindications or risks associated with this toothpaste?

There are no contraindications, abuse risks, or dependence concerns listed for this toothpaste.

Packaging Info

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

Packaging configurations for Farmasi Whitening.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the protection of teeth and the prevention of cavities. Additionally, it aids in whitening teeth by effectively removing surface stains.

Dosage and Administration

Adults and children aged 6 years and older should brush their teeth thoroughly after meals, ideally at least twice a day. Alternatively, brushing may be performed as directed by a dentist or physician. It is important to ensure that the brushing technique is effective to maintain optimal oral hygiene.

Contraindications

Use is contraindicated in children under 6 years of age. In the event of accidental ingestion of amounts exceeding those recommended for brushing, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

No specific general precautions or laboratory tests have been identified for this product. However, healthcare professionals should remain vigilant regarding the potential for accidental ingestion, particularly in young children, and ensure that caregivers are informed of the necessary actions to take in such situations.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is crucial to keep the product out of reach of children, particularly those under 6 years of age. In the event that 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.

These precautions are essential to ensure the safety and well-being of young children who may inadvertently ingest the product.

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 Farmasi Whitening (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Farmasi Whitening.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this product. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist or physician.

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 Farmasi Whitening Toothpaste (sodium fluoride paste, dentifrice) during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

No specific information regarding nursing mothers or lactation considerations is provided in the drug insert for Farmasi Whitening Toothpaste. Therefore, the effects on breastfed infants and the excretion of the product in breast milk remain unknown. Healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers on the use of this product.

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

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the individual patient's liver status when prescribing this medication.

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 relevant information is available regarding non-teratogenic effects, teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology.

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 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 tube that must be kept tightly closed when not in use. It should be stored at room temperature and must not be frozen. It is important to discard the product after opening if it is not used within the specified time frame.

Additional Clinical Information

The product is administered via the dental route. Patients, including adults and children aged 6 years and older, are advised to brush their teeth thoroughly after meals, at least twice a day, or as directed by a dentist or physician. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Farmasi Whitening, 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 Farmasi Whitening, 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.