Closys

Description

GENTLE MINT is a multi-benefit toothpaste formulated specifically for adults aged 55 and older. This 3.4 oz (96g) toothpaste provides anticavity protection, remineralizes enamel, and freshens breath while being gentle and non-irritating. The active ingredient, standardized chlorine dioxide, is protected under U.S. and foreign patents. GENTLE MINT is accepted by the American Dental Association (ADA), ensuring its efficacy in helping to prevent cavities. It is distributed by Rowpar Pharmaceutical, Inc., located in Scottsdale, AZ, and is manufactured in the USA. For more information on patents, visit CloSYS.com/patents.

Uses and Indications

This drug is indicated for the prevention of dental decay. It aids in reducing the incidence of cavities in patients.

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 or physician.

For children under 6 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Caregivers should supervise children as necessary until they are capable of brushing without assistance. It is important to emphasize that the product should not be swallowed.

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

Contraindications

Use is contraindicated in children under 6 years of age. Due to the potential risk of accidental ingestion, it is advised to keep this product out of reach of young children. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Warnings and Precautions

Healthcare professionals should ensure that the product is kept out of reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

It is imperative to educate caregivers about these warnings to mitigate risks associated with accidental ingestion. Regular monitoring of the product's use in pediatric populations is advised to ensure compliance with safety recommendations.

Side Effects

Patients should be advised to keep this product out of reach of children under 6 years of age. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. This warning highlights the potential risks associated with accidental ingestion, underscoring the importance of proper usage and supervision.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Closys (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children under 6 years of age. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is necessary.

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 or doctor. Children under 6 years of age should be instructed in proper brushing and rinsing techniques to minimize swallowing, and they should be supervised as needed until they are capable of brushing without assistance. It is important to emphasize that this product should not be swallowed.

For children under 2 years of age, consultation with a dentist or doctor is advised prior to use.

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 regarding the use of CloSYS sodium fluoride paste, dentifrice during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is recommended that pregnant patients consult their healthcare provider for personalized guidance regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific warnings or recommendations related to lactation in the provided information. Therefore, healthcare professionals may consider the use of this product in nursing mothers on a case-by-case basis, taking into account the overall clinical context.

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 the use of this medication. Consequently, there are no established 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 based on clinical judgment.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information available when contacting medical professionals or poison control for guidance.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients, particularly young children.

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 medication is administered orally. Clinicians should counsel patients to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion beyond the amount used for brushing, immediate medical assistance or contact with a Poison Control Center is advised. Patients should be instructed on proper brushing and rinsing techniques to minimize swallowing, and children should be supervised until they are capable of using the product independently. It is important to emphasize that the product should not be swallowed, and consultation with a dentist or doctor is recommended for children under 2 years of age.

Drug Information (PDF)

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

View product document (PDF)