Euthymol Extraordinary Pink Whitening

Description

EXTRAORDINARY is a fluoride toothpaste formulated to promote whiter teeth within one week. It features a pink whitening formula and is infused with wintergreen mint for flavor. The product is free from BPA, phthalates, preservatives, peroxide, and animal ingredients, ensuring a gentle yet effective oral care solution. Each tube contains a net weight of 3.7 oz (106 g) and is manufactured by LG H&H Co., Ltd., located at 58, Saemunan-ro, Jongno-gu, Seoul, Korea. For more information, visit www.lghnh.com.

Uses and Indications

This drug is indicated for the protection against dental cavities.

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 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 recommended amount 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.

Warnings

This product should be kept 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, it is crucial to seek professional assistance or contact a poison control center immediately.

Precautions

In the case of an allergic reaction, the use of this product must be discontinued without delay. Healthcare professionals should advise patients to monitor for any signs of an allergic response and to seek medical attention if such symptoms occur.

Emergency Instructions

Should accidental ingestion occur, it is essential to seek professional medical help or contact a poison control center right away. Prompt action is necessary to mitigate potential risks associated with excessive consumption.

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. It is essential for healthcare providers to monitor patients for any signs of adverse effects and to take appropriate action if necessary.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified 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 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. It is advised that children under 2 years consult a dentist before use. 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. Parents and caregivers should supervise children's brushing until good habits are established. In the event of accidental swallowing of more than the amount used for brushing, professional assistance or contact with a poison control center should be sought immediately.

Geriatric Use

Elderly patients may use Euthymol Extraordinary Pink Whitening Toothpaste; however, the prescribing information does not provide specific details regarding geriatric use, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise clinical judgment when recommending this product to geriatric patients, considering the absence of targeted studies or data that address the unique needs and potential sensitivities of elderly individuals. Monitoring for any adverse effects or reactions is advisable, as with any patient population.

Pregnancy

There is no specific information regarding the use of EUTHYMOL Extraordinary Pink 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 is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for 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 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 overdosage, it is imperative that immediate action is taken. If the product is accidentally swallowed in quantities exceeding the amount typically used for brushing, healthcare professionals should advise patients to seek professional assistance without delay. Additionally, contacting a poison control center is strongly recommended to ensure appropriate management and guidance.

Symptoms of overdosage may vary, and it is crucial for healthcare providers to monitor the patient closely for any adverse effects. Prompt intervention can significantly mitigate potential risks associated with overdosage.

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 for SPL code 90375-7.

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 various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is protected from light to maintain its integrity. Additionally, it is crucial to avoid freezing the product, as this may compromise its effectiveness. Proper handling and storage conditions are essential to ensure the product remains safe and effective for use.

Additional Clinical Information

The route of administration for the product is dental. 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 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)