Pop Feeling Peachy

Description

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

Uses and Indications

This drug is indicated for the prevention of dental caries (cavities) and the repair of enamel. It aids in protecting against cavities and contributes to freshening breath.

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 of teeth in 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 and product use.

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 safety measures.

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 closely for any signs of serious reactions, particularly allergic responses, and to take appropriate action if such events occur.

Postmarketing experience may also provide additional insights into the safety of the treatment, highlighting the importance of ongoing surveillance for adverse reactions in the broader patient population.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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, 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. Parents and caregivers are encouraged to 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 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 POP Feeling Peachy sodium fluoride paste, dentifrice, in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific contraindications. However, it is advisable to monitor breastfed infants for any potential effects, as no data on excretion in breast milk or effects on nursing infants are available.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert text. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment and monitoring based on the patient's overall health status and renal function.

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 imperative that immediate action is taken. If the product is accidentally swallowed in quantities exceeding the amount typically used for brushing, the individual should seek professional medical assistance without delay.

Healthcare professionals are advised to contact a poison control center for further guidance on managing the situation. Prompt intervention is crucial to mitigate any potential adverse effects 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available 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 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 Pop Feeling Peachy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)