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Eurofresh Whitening

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Active ingredient
Sodium Fluoride 1.08 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
November 5, 2023
Active ingredient
Sodium Fluoride 1.08 mg/1 g
Other brand names
Dosage form
Paste, Dentifrice
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
November 5, 2023
Manufacturer
Farmasi US LLC
Registration number
M021
NDC root
74690-008

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

This product is designed to help protect your teeth against cavities while also assisting in whitening them. By using this product, you can maintain better oral health and achieve a brighter smile. It's a simple addition to your dental care routine that can make a positive difference in the appearance and health of your teeth.

Uses

You can use this product to help protect your teeth against cavities, which are small holes that can form in your teeth due to decay. Additionally, it can assist in whitening your teeth, giving you a brighter smile.

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 maintaining your dental health.

Dosage and Administration

To keep your teeth healthy, it's important to brush thoroughly after meals or at least twice a day. This applies to both adults and children aged 2 years and older. If you have any specific instructions from your dentist or physician, be sure to follow those as well.

For children under 6 years old, it's essential to teach them good brushing and rinsing habits to help prevent swallowing toothpaste. If your child is under 2 years old, it's best to consult with a dentist or physician for guidance on how to care for their teeth properly.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should not take it if you experience any irritation that continues or worsens. While there are no specific contraindications, controlled substance classifications, or noted risks of abuse or dependence associated with this medication, always prioritize your health and safety. If you have any concerns or experience adverse effects, consult your healthcare provider for guidance.

Side Effects

If you experience any irritation while using this medication, it is important to stop using it and consult your healthcare provider. Persistent irritation could indicate a reaction that needs attention. Always prioritize your comfort and safety when using any medication.

Warnings and Precautions

If you experience any irritation while using this product, stop using it immediately and do not continue if the irritation persists. 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 right away.

In case of accidental swallowing of a larger amount, you should also get medical help or reach out to a Poison Control Center immediately. Always prioritize safety and be aware of how to respond in case of an emergency.

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 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 about the use of Eurofresh Whitening Toothpaste during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product's guidelines.

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, to ensure they are safe for you and your baby.

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 (the process of producing milk) in the information provided. This suggests that the product is generally considered safe for use during breastfeeding. 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

It's important to keep this product out of reach of children under 6 years old. For children under 6, make sure to teach them good brushing and rinsing habits to help prevent swallowing the product. If your child is 2 years or older, encourage them to brush their teeth thoroughly after meals or at least twice a day, or follow the instructions given by their dentist or physician.

For children under 2 years, it's best to consult with a dentist or physician before use to ensure their safety and proper care.

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 may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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, always ensure that your healthcare team is aware of all the medications you are using, as this helps them provide the safest and most effective care tailored to your needs.

By discussing your full medical history and any current treatments, you can help prevent potential issues and ensure that your healthcare provider can make informed decisions about your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication topically, which means applying it directly to the skin. If you are an adult or a child aged 2 years and older, make sure to brush your teeth thoroughly after meals or at least twice a day, or follow your dentist's or physician's instructions. For children under 6, it's important to teach them good brushing and rinsing habits to avoid swallowing the product. If your child is under 2 years old, consult a dentist or physician for guidance.

Always supervise children while they are using this product until they can do so independently. Remember not to swallow the medication, and be sure to rinse away any toothpaste residue thoroughly after brushing.

FAQ

What does this toothpaste do?

This toothpaste helps protect against cavities and whiten teeth.

Who can use this toothpaste?

Adults and children 2 years and older can use this toothpaste. Children under 2 years should consult a dentist or physician.

How should I use this toothpaste?

Brush your teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.

Are there any warnings for using this toothpaste?

Do not use if irritation occurs and persists. Keep out of reach of children under 6 years.

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

Get medical help or contact a Poison Control Center right away if more than used for brushing is accidentally swallowed.

Is this toothpaste safe for pregnant or nursing women?

There are no specific warnings or recommendations regarding the use of this toothpaste during pregnancy or lactation.

How should I store this toothpaste?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Packaging Info

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

Packaging configurations for Eurofresh Whitening.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the protection against cavities and for the whitening of teeth.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

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

For children under 6 years of age, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing.

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

Contraindications

Use is contraindicated in patients who experience irritation that persists after initial application. Discontinuation is advised in such cases to prevent exacerbation of symptoms. No other contraindications have been identified.

Warnings and Precautions

Irritation at the application site may occur; if such irritation persists, the product should be discontinued immediately.

It is imperative to keep this product out of reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally ingested, it is crucial to seek medical assistance or contact a Poison Control Center without delay.

In cases of accidental ingestion exceeding the recommended dosage, immediate medical help should be sought, or a Poison Control Center should be contacted to ensure appropriate management and care.

No specific instructions for discontinuation or consultation with a healthcare provider have been provided in the insert.

Side Effects

Patients should be monitored for signs of irritation during treatment. If irritation occurs and persists, discontinuation of the therapy is advised. Adverse reactions may vary in severity and frequency among individuals. It is essential for healthcare providers to assess the risk of continued use in the presence of persistent irritation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions between this drug and laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Eurofresh Whitening.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children in this age group, it is important to instruct them in good brushing and rinsing habits to minimize the risk of swallowing.

For children aged 2 years and older, it is recommended to brush teeth thoroughly after meals or at least twice a day, or to use the product as directed by a dentist or physician.

For infants and children under 2 years, consultation with a dentist or physician is advised prior to use.

Geriatric Use

There is no specific information available 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 Eurofresh Whitening Toothpaste during pregnancy. The prescribing information 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

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 concerning lactation. Therefore, healthcare professionals may consider the use of this product in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

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

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, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include assessing the patient's condition and providing supportive care as necessary. It is advisable to follow established protocols for the treatment of overdosage, which may involve symptomatic treatment and monitoring of vital signs.

In all cases of suspected overdosage, the involvement of a medical professional is crucial to ensure appropriate care and intervention.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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. Instruct patients that if more than the recommended amount for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately.

Additionally, healthcare providers should inform patients to discontinue use if any irritation occurs and persists. It is important for patients to be aware of these safety measures to ensure proper use and minimize risks associated with the product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients, particularly those with children, to supervise their use until they are capable of using the product without assistance. It is important to instruct patients not to swallow the product and to ensure that any toothpaste residue is thoroughly rinsed away after brushing.

For adults and children aged 2 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. For children under 6 years, guidance on good brushing and rinsing habits should be provided to minimize the risk of swallowing. For children under 2 years, consultation with a dentist or physician is advised.

Drug Information (PDF)

This file contains official product information for Eurofresh 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 Eurofresh 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

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.