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 designed without the inclusion of BPA, phthalates, preservatives, peroxide, or animal ingredients. Each tube contains a net weight of 0.7 oz (20 g). EXTRAORDINARY 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 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 that the product is not swallowed.

For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers should supervise the brushing of children's teeth 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 dental care.

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 immediately if an allergic reaction occurs.

Warnings and Precautions

It is imperative to keep this product out of the 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 contact with a poison control center is recommended.

In addition, healthcare professionals should be vigilant for signs of allergic reactions. Should any allergic reaction occur, the use of the product must be discontinued immediately to mitigate potential adverse effects.

Side Effects

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

Clinical trials and postmarketing experiences have provided insights into the safety profile of the treatment. It is essential for healthcare providers to monitor patients for any signs of adverse reactions and to take appropriate action if necessary.

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, routine monitoring or dosage adjustments related to drug or laboratory test interactions are not required.

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, and it should not be swallowed. In the event of accidental ingestion of more than the amount used for brushing, professional assistance or contact with a poison control center is advised immediately.

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. Caregivers should supervise children's brushing until proper oral hygiene habits are established. For children under 2 years of age, consultation with a dentist is recommended 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 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 are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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 are no established 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 available information.

Overdosage

In the event of overdosage, it is critical to take immediate action. If an individual accidentally swallows an amount greater than what is typically used for brushing, it is imperative to seek professional assistance without delay. Healthcare professionals should advise contacting a poison control center for further guidance.

Symptoms of overdosage may vary, and prompt evaluation by a medical professional is essential to determine the appropriate management strategy. It is important to monitor the patient closely for any adverse effects and to provide supportive care as needed.

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 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 of accidental swallowing of 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 any signs of an allergic reaction develop.

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. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

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. To minimize the risk of swallowing, a pea-sized amount is recommended for children under 6, and caregivers 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.

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