Pop Feeling Peachy

Description

Fluoride toothpaste formulated with hydroxyapatite and vitamins E and B3. The product is presented in a net weight of 4.2 ounces (120 grams). It is distributed by LG H&H Co., Ltd., located at 58, Saemunan-ro, Jongno-gu, Seoul, Korea. The toothpaste is manufactured in Korea and is available for further information at www.oralcarebypop.com.

Uses and Indications

This drug is indicated for the prevention and treatment of dental caries by helping to protect against cavities and repair enamel. Additionally, it serves to freshen breath, contributing to overall oral health.

There are no teratogenic or nonteratogenic effects associated with this drug.

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 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 should supervise the brushing process for children 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 is contraindicated in individuals who have a known allergy to any component of the product. In the event of an allergic reaction, discontinue use immediately.

Additionally, the product should not be swallowed. If accidental ingestion occurs, seek professional assistance or contact a poison control center without delay.

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. 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 dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Pop Feeling Peachy (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 under 2 years, it is advised to 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 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. Caregivers should supervise children's brushing until proper oral hygiene 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 is necessary.

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, given the lack of targeted data.

Pregnancy

There is no specific information regarding the use of POP Feeling Peachy sodium fluoride paste, dentifrice 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 regarding the use of this product during pregnancy.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for POP Feeling Peachy sodium fluoride paste, dentifrice. Therefore, the effects on lactating mothers and breastfed infants are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of overdosage, it is imperative that immediate action is taken. If an individual accidentally swallows an amount greater than what is typically used for brushing, it is crucial 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 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 any allergic reaction occurs. It is important for patients to be aware of the signs of an allergic reaction and to seek medical attention if they experience any symptoms.

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. 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 Pop Feeling Peachy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)