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Euthymol 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 2025
Label revision date
June 2, 2025
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 2025
Label revision date
June 2, 2025
Manufacturer
LG HOUSEHOLD & HEALTH CARE LTD.
Registration number
M021
NDC root
53208-566

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 medication is designed to help protect your teeth against cavities, which are small holes that can form in your teeth due to decay. By using this product, you can support your dental health and reduce the risk of developing cavities, contributing to a healthier smile.

Uses

You can use this product to help protect against cavities, which are small holes in your teeth caused by decay. It's important to maintain good oral hygiene, and this product can be a helpful part of your routine to keep your teeth healthy.

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

Dosage and Administration

When using this medication, it's important to remember that you should not swallow it. If you accidentally swallow more than what is needed for brushing your teeth, seek professional help or contact a poison control center immediately. This is crucial for your safety.

Additionally, if you notice any signs of an allergic reaction, such as rash, itching, or difficulty breathing, stop using the product right away. Your health and well-being are the top priority, so always be attentive to how your body responds while using this medication.

What to Avoid

It's important to ensure that any medication you use is kept safe and out of reach of children, especially those under 6 years of age. This precaution helps prevent accidental ingestion, which can be dangerous for young children.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use medications responsibly.

Side Effects

If you experience an allergic reaction while using this medication, it is important to stop using it right away. Allergic reactions can include symptoms like rash, itching, or difficulty breathing. Additionally, please ensure that this medication is kept out of reach of children, especially those under 6 years of age, to prevent any accidental ingestion.

Warnings and Precautions

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

If you experience any signs of an allergic reaction, such as rash, itching, or difficulty breathing, stop using the product right away and call your doctor. There are no specific laboratory tests required for this product, but always prioritize your safety and well-being.

Overdose

If you accidentally swallow more of this product than intended for brushing, it’s important to seek professional help or contact a poison control center immediately. Overdosing can lead to serious health issues, so don’t hesitate to get assistance.

Additionally, if you experience any signs of an allergic reaction, such as rash, itching, or difficulty breathing, stop using the product right away and seek medical attention. Your safety is the top priority, so always be cautious and aware of how much you are using.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the safety or use of this medication during pregnancy. This means that there are no established guidelines regarding dosage adjustments or special precautions for pregnant individuals.

Given this lack of information, it's crucial to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children under 6 years old. For children aged 2 years and older, you should encourage them to brush their teeth thoroughly, ideally after each meal or at least twice a day, following your dentist's advice. When helping younger children, use only a pea-sized amount to reduce the risk of swallowing.

Make sure to supervise their brushing until they develop good habits. If your child is under 2 years old, it's best to consult with a dentist before using this product.

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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 even if no interactions are listed, discussing all your medications and any lab tests with your healthcare provider is crucial. This helps to avoid any potential issues and ensures that you receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion. Remember, this product is not meant to be swallowed, so please handle it with care and follow these guidelines closely for safe use.

Additional Information

You should use this dental product by brushing your teeth thoroughly, ideally after each meal or at least twice a day, unless your dentist advises otherwise. It's important not to swallow the product. For children under 6, use only a pea-sized amount to help minimize swallowing, and supervise their brushing until they develop good habits. If your child is under 2 years old, consult a dentist for guidance on use.

FAQ

What is the primary use of this drug?

This drug helps protect against cavities.

What should I do if I accidentally swallow this drug?

If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away.

How should I use this drug?

Adults and children 2 years of age and older should brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.

Is there any specific guidance for children under 6 years?

For children under 6, use a pea-sized amount to minimize swallowing and supervise their brushing until good habits are established.

What should I do if an allergic reaction occurs?

If an allergic reaction develops, discontinue use immediately.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Is this drug safe for use during pregnancy or by nursing mothers?

There is no specific information regarding safety concerns or recommendations for use during pregnancy or by nursing mothers.

How should I store this drug?

Store at room temperature and keep out of reach of children.

Packaging Info

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

Packaging configurations for Euthymol Whitening.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is packaged in a bottle. It is represented visually in a JPEG format, with a reference value of 18400231_EUTHYMOL_40g Tube.jpg.

Uses and Indications

This drug is indicated for the protection against cavities.

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

Dosage and Administration

Healthcare professionals should instruct patients not to swallow the product. In the event of accidental ingestion of an amount exceeding that used for brushing, patients should seek professional assistance or contact a poison control center immediately.

If any signs of an allergic reaction occur, the patient must discontinue use of the product without delay.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this age group. Additionally, it is advised to keep the product out of reach of children to avoid accidental ingestion or misuse.

Warnings and Precautions

It is imperative to keep this product out of reach of children under 6 years of age to prevent accidental ingestion.

Users are advised not to swallow the product. In the event of accidental ingestion of an amount exceeding that typically used for brushing, it is crucial to seek professional assistance or contact a poison control center immediately.

In the case of an allergic reaction, the user must discontinue use immediately and consult a healthcare professional.

No specific laboratory tests are recommended for monitoring the use of this product. However, vigilance for any adverse reactions is essential to ensure patient safety.

Side Effects

In clinical trials and postmarketing experiences, patients have reported various adverse reactions associated with the use of this medication.

Serious adverse reactions may occur, and if an allergic reaction develops, it is imperative to discontinue use immediately.

Additionally, it is crucial to keep this medication out of reach of children, particularly those under 6 years of age, to prevent accidental ingestion or misuse.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. 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 Euthymol Whitening (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Euthymol Whitening.
Details

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of the product. For children aged 2 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years. It is important to supervise children's brushing until good oral hygiene habits are established. For children under 2 years, consultation with a dentist is advised before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as there is no available data to guide appropriate dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined 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 prescribing information.

Overdosage

In the event of overdosage, it is imperative that the individual does not swallow the product. Should accidental ingestion occur, particularly if the amount exceeds that which is typically used for brushing, immediate professional assistance should be sought. It is advisable to contact a poison control center without delay to ensure appropriate management.

Healthcare professionals should be aware that if an allergic reaction develops following overdosage, the use of the product must be discontinued immediately. Monitoring for symptoms of an allergic reaction is crucial, and appropriate interventions should be initiated based on the severity of the reaction.

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.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is imperative to keep the product out of reach of children. Additionally, users are advised not to swallow the product. Proper adherence to these guidelines will help ensure the integrity and safety of the product during its use.

Additional Clinical Information

The product is administered via the dental route. Patients, including 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. It is important not to swallow the product; to minimize swallowing in children under 6 years, a pea-sized amount should be used, and adult supervision is recommended until good brushing habits are established. For children under 2 years, consultation with a dentist is advised.

Drug Information (PDF)

This file contains official product information for Euthymol 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 Euthymol 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.

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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.