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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
May 19, 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
May 19, 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 product is designed to help protect against cavities, which are small holes in your teeth caused by decay. By using this product, you can support your dental health and maintain a brighter smile. It is part of a whitening set, indicating that it may also help improve the appearance of your teeth while providing cavity protection.

Uses

You can use this product to help protect your teeth against cavities. Cavities are small holes that can form in your teeth due to decay, often caused by bacteria. By using this product, you can support your dental health and reduce the risk of developing cavities, keeping your smile bright and healthy.

Dosage and Administration

When using this medication, it's important to remember that you should not swallow it. This product is meant for topical use only, so make sure to apply it as directed. If you accidentally swallow more than what is needed for brushing, seek professional help or contact a poison control center immediately.

Additionally, be aware of any signs of an allergic reaction, such as rash, itching, or difficulty breathing. If you experience any of these symptoms, stop using the product right away and consult a healthcare professional. Your safety is the top priority, so always follow the instructions carefully.

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 under 6 years of age to prevent any accidental ingestion. Your safety is a priority, so always be aware of how your body responds to any medication.

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. Your safety is a priority, so please take these precautions seriously.

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. This is crucial to ensure your safety and receive the appropriate care.

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 health and safety are the top priority, so don’t hesitate to reach out for help if you have concerns.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care 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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose 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 considering this medication, it’s important to consult with a healthcare provider. 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 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 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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 way, you can avoid any potential issues and receive the best care tailored to your needs.

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

This medication is administered through the mouth, specifically for dental use. It's important to keep it out of reach of children under 6 years old. You should not swallow the medication; if you accidentally swallow more than what is used for brushing, seek professional help or contact a poison control center immediately.

If you notice any signs of an allergic reaction, stop using the product right away. 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 before use.

FAQ

What is the main benefit of this drug?

This drug helps protect against cavities.

What should I do if I accidentally swallow this product?

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

What age group can use this product?

Adults and children 2 years of age and older can use this product. For children under 2 years, you should ask a dentist.

How should children under 6 use this product?

To minimize swallowing, use a pea-sized amount and supervise their brushing until good habits are established.

What should I do if I experience an allergic reaction?

If an allergic reaction develops, discontinue use immediately.

Are there any specific warnings for this product?

Yes, keep it out of reach of children under 6 years of age and do not swallow.

How should I store this product?

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

Is there any information regarding use during pregnancy or nursing?

There is no specific information provided regarding use during pregnancy or by nursing mothers.

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 identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the protection against dental cavities. It is designed to support oral health by reducing the risk of cavity formation in patients.

Dosage and Administration

Healthcare professionals should instruct patients not to swallow the product. In the event of accidental ingestion of more than the amount intended for brushing, it is imperative to seek professional assistance or contact a poison control center immediately.

Patients should be advised to discontinue use if any allergic reaction occurs.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm due to the product's formulation or effects in this age group.

Warnings and Precautions

It is imperative to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate professional assistance should be sought, or a poison control center should be contacted without delay.

Healthcare professionals should be vigilant for signs of allergic reactions. Should any allergic reaction occur, the use of the product must be discontinued immediately, and the patient should consult their healthcare provider for further evaluation and management.

No specific general precautions or laboratory tests are recommended for the safe use of this product. However, the aforementioned warnings and instructions for emergency medical help and discontinuation of use in the event of an allergic reaction are critical for ensuring patient safety.

Side Effects

In clinical use, patients may experience various adverse reactions. It is crucial to monitor for signs of allergic reactions; should any develop, the use of the product must be discontinued immediately to prevent further complications.

Additionally, it is important to note that the product should be kept out of reach of children under 6 years of age to ensure their safety.

Drug Interactions

No specific drug interactions have been identified in the available data. 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 Euthymol Whitening (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Euthymol Whitening.
Details

Pediatric Use

Pediatric patients should be supervised during tooth brushing until good habits are established. 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. A pea-sized amount of toothpaste should be used in children under 6 years of age to minimize swallowing.

For children under 2 years, consultation with a dentist is advised before use. Additionally, this product should be kept out of reach of children under 6 years of age to ensure safety.

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 lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any plans for pregnancy with their healthcare provider.

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 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

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 healthcare professionals take immediate action. If a patient accidentally swallows an amount greater than what is typically used for brushing, they should seek professional assistance or contact a poison control center without delay.

Should an allergic reaction occur, it is crucial to discontinue use immediately and initiate appropriate medical intervention. Monitoring for symptoms of an allergic reaction is essential, as timely management can mitigate potential complications.

Healthcare providers are advised to follow established protocols for managing overdosage and allergic reactions, ensuring that patients receive the necessary care promptly.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 to maintain its efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. Additionally, users are advised not to swallow the product. Proper adherence to these guidelines will help ensure the product remains safe and effective for use.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of reach of children under 6 years of age and to avoid swallowing. In the event of accidental ingestion of more than the amount used for brushing, patients should seek professional assistance or contact a poison control center immediately. If an allergic reaction occurs, use should be discontinued right away. For children under 6, it is recommended to use a pea-sized amount to minimize swallowing, and parents should supervise brushing until good habits are established. Additionally, for children under 2 years of age, 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.

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.