Sodium fluoride

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It functions as an anti-cavity toothpaste formulated with bio-available calcium, phosphate, and fluoride, which work synergistically to enhance oral health and strengthen tooth enamel.

Dosage and Administration

For adults and children aged 2 years and older, a small, pea-sized amount of MI Paste ONE Kids should be applied to the toothbrush. The product should be brushed onto the teeth for a duration of 2 minutes. After brushing, patients are advised to expectorate and refrain from eating or drinking for 30 minutes to maximize the product's effectiveness. This application should be performed twice daily. It is important to securely replace the cap after each use to maintain product integrity.

For children under 2 years of age, it is recommended to consult a dentist or physician prior to use.

Contraindications

Use is contraindicated in patients with a known allergy to milk protein or hydroxybenzoates. Due to the potential for severe allergic reactions, administration in these individuals may pose significant health risks.

Warnings and Precautions

It is imperative to keep this product out of reach of children under 6 years of age to prevent accidental ingestion and potential harm.

In the event that more than the recommended amount of paste is accidentally swallowed, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

This product is contraindicated in patients with known allergies to milk proteins or hydroxybenzoates. Healthcare professionals should ensure that patients are screened for these allergies prior to use.

Should an allergic reaction occur, it is essential to discontinue use immediately. The affected individual should rinse their mouth thoroughly with water and seek medical advice to address the reaction appropriately.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount of paste is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately.

The product is contraindicated in patients with known allergies to milk protein or hydroxybenzoates. In the case of an allergic reaction, it is advised to discontinue use, rinse the mouth with water, and seek medical advice promptly.

These precautions are essential to ensure the safety and well-being of patients using this product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mipaste One Kids Bubble Gum. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

For pediatric patients aged 2 years and older, a small, pea-size amount of MI Paste ONE Kids should be applied to the toothbrush. In children under 2 years of age, it is advised to consult a dentist or physician prior to use.

Caution is warranted as MI Paste ONE Kids should be kept out of reach of children under 6 years of age. In the event that more than the recommended amount of paste is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of MIPASTE ONE KIDS BUBBLE GUM during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before prescribing this product to pregnant patients.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

Renal Impairment

Patients with renal impairment may not have specific 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 lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted in these patients to ensure safety and therapeutic effectiveness.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the recommended amount of the paste, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can mitigate potential adverse effects associated with overdosage. Monitoring the patient for any symptoms that may arise is essential, although specific symptoms related to this overdosage have not been detailed.

Management of overdosage should focus on supportive care and symptomatic treatment as necessary. It is advisable to follow established protocols for the management of overdose cases, ensuring that the patient receives appropriate evaluation and treatment based on their clinical presentation.

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 for the product associated with 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. Instruct patients that if more than the recommended amount of paste is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is important to inform patients not to use this product if they have a known allergy to milk protein or hydroxybenzoates. In the event of an allergic reaction, patients should be instructed to stop using the product, rinse their mouth with water, and seek medical advice promptly.

Storage and Handling

The product is supplied in a configuration that includes an NDC number, which is essential for identification and inventory management. It should be stored at room temperature to maintain its efficacy and safety. After each use, it is important to keep the cap tightly closed to prevent contamination and preserve the product's integrity. Additionally, any unused portion should be discarded after opening if not utilized within the specified time frame, ensuring optimal quality and safety for the user.

Additional Clinical Information

For patients aged 2 years and older, MI Paste ONE Kids should be applied as a small, pea-sized amount to a toothbrush. Clinicians recommend brushing for 2 minutes, followed by expectoration, and advise avoiding eating or drinking for 30 minutes post-brushing. This product is intended for dental use and should be administered twice daily.

Clinicians should counsel patients to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of more than the recommended amount, immediate medical assistance or contact with a Poison Control Center is advised. The product is contraindicated in patients with allergies to milk protein or hydroxybenzoates. If an allergic reaction occurs, patients should discontinue use, rinse their mouth with water, and seek medical advice.

Drug Information (PDF)

This file contains official product information for Mipaste One Kids Bubble Gum, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)