Maintenance Rinse

Description

The product is identified by the SPL Code 34089-3. It features maintenance labels in three flavors: Mint, Citrus, and Grape. These labels are designed for enclosure applications, providing clear identification and information relevant to the product's use.

Uses and Indications

This drug is indicated for the prevention of dental caries (cavities). It is intended for use in individuals at risk of developing dental caries, including children and adults. Regular use as part of a comprehensive oral hygiene regimen is recommended to maximize its effectiveness in reducing the incidence of cavities.

Dosage and Administration

Adults and children aged 6 years and older should use the rinse once daily, following brushing with toothpaste. The recommended method involves vigorously swishing 10 mL of the rinse between the teeth for one minute before spitting it out. It is imperative that the rinse is not swallowed. After rinsing, patients should refrain from eating or drinking for a period of 30 minutes to ensure optimal efficacy.

For children under 12 years of age, it is essential to instruct them in proper rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child is capable of using the rinse independently.

For children under 6 years of age, consultation with a dentist or physician is advised prior to use.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. Ensure that the product is kept out of reach of children to prevent potential harm. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event that more than the recommended amount used for rinsing is swallowed, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and seek dental consultation if any unusual symptoms arise during the use of this product. Monitoring for adverse reactions is essential to ensure patient safety and effective management of any potential complications.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is imperative to keep the product out of reach of children to prevent accidental ingestion. In the event that more than the recommended amount for rinsing is accidentally swallowed, patients are advised to seek medical assistance or contact a Poison Control Center immediately.

Additionally, if patients experience any unusual symptoms while using the product, they should discontinue use and promptly contact their dentist for further evaluation and guidance. These precautions are essential to ensure the safety and well-being of individuals using the product.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Maintenance Rinse (anticaries). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be supervised during the use of this product to ensure proper rinsing habits and minimize the risk of swallowing. Children under 12 years of age should be instructed in good rinsing practices. For children under 6 years of age, consultation with a dentist or physician is recommended prior to use.

For children aged 6 years and older, the product is indicated for use once daily after brushing teeth with toothpaste. The recommended dosage is to vigorously swish 10 mL of the rinse between the teeth for one minute and then spit it out. It is important to instruct pediatric patients not to swallow the rinse and to avoid eating or drinking for 30 minutes following use.

In the event that more than the recommended amount is accidentally swallowed, medical assistance or contact with a Poison Control Center should be sought immediately. Additionally, the product should be kept out of reach of children to prevent accidental ingestion.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

Renal Impairment

There is no specific information available 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 patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available 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.

Overdosage

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

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

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 provided data.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

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 temperatures below 30 degrees Celsius (86 degrees Fahrenheit) to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. Proper storage conditions are crucial to ensure the product remains safe and effective for use.

Additional Clinical Information

Patients aged 6 years and older should use the rinse once daily after brushing their teeth with toothpaste. The recommended method involves vigorously swishing 10 mL of the rinse between the teeth for one minute before spitting it out. It is important that patients do not swallow the rinse and refrain from eating or drinking for 30 minutes following the rinsing.

Clinicians should advise that children under 12 years of age be instructed in proper rinsing techniques to minimize the risk of swallowing. Supervision is recommended until children are capable of using the rinse independently. For children under 6 years of age, consultation with a dentist or physician is advised.

Drug Information (PDF)

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

View product document (PDF)