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.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

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. It is recommended to brush for a duration of 2 minutes, followed by expectoration. Patients should avoid eating or drinking for 30 minutes after brushing to maximize the effectiveness of the product.

The product should be used twice daily to ensure optimal results. For children under 2 years of age, it is advised to consult a dentist or physician prior to use.

Contraindications

Use is contraindicated in patients with a known allergy to milk proteins or hydroxybenzoates.

Additionally, the product should not be used in 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. If an allergic reaction occurs, discontinue use, rinse the mouth with water, and seek medical advice.

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 contact a Poison Control Center without delay.

This product is contraindicated for use in patients with known allergies to milk proteins or hydroxybenzoates. Healthcare professionals should carefully assess patient history for these allergies prior to recommending this product.

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 any adverse effects.

Side Effects

Patients may experience allergic reactions to the product. In the event of an allergic reaction, it is advised to discontinue use, rinse the mouth with water, and seek medical advice. The product should not be used in patients with known allergies to milk protein or hydroxybenzoates.

Warnings associated with the use of this product include the necessity to keep it out of reach of children under 6 years of age. Additionally, if a patient accidentally swallows more than the recommended amount of paste during brushing, it is imperative to seek medical help or contact a Poison Control Center immediately.

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 Cotton Candy. 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 recommended.

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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of MI Paste One Kids during pregnancy has not been established. There are no specific contraindications for its use in pregnant patients, and the potential risks to the fetus are not explicitly stated in the prescribing information. Additionally, no dosage modifications for pregnant individuals are provided, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should consider these factors when advising women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of MI Paste One Kids in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this population to ensure safety and efficacy.

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 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 overdosage are not detailed in the available data.

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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include rash, urticaria, and angioedema.

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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness. After each use, the cap must be securely replaced to ensure proper sealing and prevent contamination.

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. MI Paste ONE Kids 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 Cotton Candy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)