Pop Gel Pumpin Strawberry

Description

This gel toothpaste is designed for use with electric toothbrushes, providing a fluoride release that is three times faster compared to traditional tube toothpaste when used with such devices. It is formulated to repair and protect enamel. The product is packaged in a net weight of 5.64 ounces (160 grams) and features a Pumpin' Strawberry flavor. It is distributed by LG H&H Co., Ltd., located at 58, Saemunan-ro, Jongno-gu, Seoul, Korea, and is manufactured in Korea. For more information, visit www.oralcarebypop.com.

Uses and Indications

This drug is indicated for the protection against cavities.

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

Dosage and Administration

Adults and children aged 2 years and older should brush their teeth thoroughly, preferably after each meal or at least twice a day, 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 exceeding 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 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 what is typically 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.

No specific general precautions or laboratory tests are recommended for this product; however, vigilance regarding the aforementioned warnings is essential for safe usage.

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, as these may necessitate prompt intervention.

Postmarketing experiences have also highlighted the importance of vigilance regarding adverse reactions, reinforcing the need for immediate discontinuation of the treatment upon the onset of any allergic symptoms.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Pop Gel Pumpin Strawberry (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, the recommended practice is 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 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 recommended.

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 Gel Pumpin' Strawberry (sodium fluoride paste, dentifrice) 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. It is recommended that the potential benefits be weighed against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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 this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 an individual accidentally swallows more than the recommended amount 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 question.

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 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 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 supervision during brushing is encouraged until proper habits are established. For children under 2 years, consultation with a dentist is advised. If any allergic reaction occurs, use should be discontinued immediately.

Drug Information (PDF)

This file contains official product information for Pop Gel Pumpin Strawberry, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)