Euthymol Extraordinary Pink Whitening

Description

EXTRAORDINARY is a fluoride toothpaste formulated to promote whiter teeth in just one week. It features a pink whitening formula with a wintergreen mint flavor. The product is manufactured without the inclusion of BPA, phthalates, preservatives, peroxide, or animal ingredients. Each tube contains a net weight of 3.7 oz (106 g) and is distributed by LG H&H Co., Ltd., located at 58, Saemunan-ro, Jongno-gu, Seoul, Korea. For more information, visit www.lghnh.com. This product is made in Korea.

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

Adults and children aged 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount of the product should be used to minimize the risk of swallowing. Caregivers are advised to supervise children's brushing until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist for appropriate guidance on usage.

Contraindications

Use of this product is contraindicated in the following situations:

Swallowing the product is not advised. In the event of accidental ingestion beyond the amount used for brushing, seek professional assistance or contact a poison control center immediately.

Discontinue use if an allergic reaction occurs.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Children under the age of 6 should be kept out of reach of this product 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.

In the case of an allergic reaction, it is crucial to discontinue use immediately and consult a healthcare professional.

Healthcare providers should remain vigilant for any signs of adverse reactions and ensure that patients are informed about the importance of following these guidelines to mitigate risks associated with the product's use.

Side Effects

Patients may experience adverse reactions during treatment. In the event of an allergic reaction, it is imperative to discontinue use immediately.

The safety profile of the treatment has been evaluated in clinical trials, where various adverse reactions were reported. Continuous monitoring for any signs of adverse effects is recommended to ensure patient safety.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

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 daily, or as directed by a dentist. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years. Parents or caregivers should supervise children's brushing until proper oral hygiene habits are established.

For children under 2 years of age, it is advised to consult a dentist before use. In the event of accidental swallowing of more than the amount used for brushing, professional assistance should be sought immediately, or a poison control center should be contacted.

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 EUTHYMOL Extraordinary Pink Whitening Toothpaste 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 about the use of this product during pregnancy. It is recommended that pregnant patients consult their healthcare provider for personalized guidance.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of specific guidance when advising lactating mothers.

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 information available regarding hepatic impairment, including dosage adjustments, special monitoring, or precautions for patients with compromised liver function. Therefore, no specific recommendations can be made for the use of this medication in patients with hepatic impairment. It is advised that healthcare professionals exercise caution and consider individual patient circumstances when prescribing this medication to patients with liver problems.

Overdosage

In the event of overdosage, it is imperative that the individual does not swallow the product. If accidental ingestion occurs, particularly if the amount exceeds that which is typically used for brushing, immediate professional assistance should be sought. Healthcare professionals are advised to contact a poison control center without delay to ensure appropriate management and intervention.

Symptoms of overdosage may vary, and prompt evaluation by a medical professional is essential to determine the necessary course of action. It is crucial to follow established protocols for managing overdosage to mitigate potential risks and ensure patient safety.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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.

Patients should be informed not to swallow the product. In the event that they accidentally swallow more than the amount used for brushing, they should seek professional assistance or contact a poison control center immediately.

Additionally, healthcare providers should instruct patients to discontinue use immediately if they experience any signs of an allergic reaction.

Storage and Handling

The product is supplied in packaging that includes 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. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of reach of children, particularly those 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. It is recommended to use only a pea-sized amount for children under 6 to minimize swallowing, and parents should supervise children's brushing until proper 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 Extraordinary Pink Whitening, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)