X-Pur Opti-Rinse Plus

Description

The product is supplied in a 500 mL container, with the National Drug Code (NDC) 77982-112-11.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 6 years and older are instructed to use the rinse once daily, following the brushing of teeth with toothpaste. The cap should be removed, and 10 milliliters of the rinse should be poured into the cap, ensuring that the liquid does not exceed the 10 mL mark indicated on the inside of the cap. The user should then vigorously swish the 10 milliliters of rinse between the teeth for a duration of 1 minute before spitting it out. It is imperative that the rinse is not swallowed. After rinsing, individuals should refrain from eating or drinking for 30 minutes to allow for optimal efficacy.

For children under 12 years of age, it is essential to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing the rinse. Supervision may be required until the child is capable of using the product without assistance.

For children aged 6 years and under, consultation with a dentist or doctor is recommended prior to use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if more than the recommended amount for rinsing is accidentally swallowed, medical assistance should be sought immediately or contact a Poison Control Center. Additionally, if symptoms persist or the condition worsens after regular use, it is recommended to discontinue use and consult a doctor or dentist.

Warnings and Precautions

It is imperative to keep this product out of the reach of children. In the event that more than the recommended amount for rinsing is accidentally ingested, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a doctor or dentist if symptoms persist or if the condition worsens following regular use. This precaution is essential to ensure patient safety and to facilitate appropriate medical evaluation and intervention if necessary.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. In the event that more than the recommended amount is accidentally swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Additionally, if symptoms persist or the condition worsens after regular use, patients are advised to discontinue use and consult a doctor or dentist. This precaution is essential to ensure the safety and well-being of individuals using the product.

It is important to keep this product out of the reach of children to prevent accidental ingestion.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of X-Pur Opti-Rinse Plus (anticavity fluoride rinse). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of the reach of children. In the event that more than the recommended amount for rinsing is accidentally swallowed, medical assistance or contact with a Poison Control Center is advised immediately.

For children aged 6 years and older, the product is to be used once daily after brushing teeth with toothpaste. It is important to instruct children under 12 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Supervision is recommended for children until they are capable of using the product without assistance.

For children aged 6 years and under, consultation with a dentist or doctor is recommended prior to use.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There is no specific information available regarding the use of this medication 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.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 overdosage, it is crucial to ensure that the product is kept out of the reach of children. Accidental ingestion of amounts exceeding those recommended for rinsing may lead to adverse effects.

Should an individual swallow more than the prescribed amount, immediate medical assistance should be sought. It is advisable to contact a Poison Control Center without delay to receive appropriate guidance and intervention. Prompt action is essential to mitigate potential risks associated with overdosage.

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 seek immediate medical assistance or contact a Poison Control Center if more than the recommended amount for rinsing is accidentally swallowed. It is important for patients to understand the potential risks associated with improper use.

Additionally, healthcare providers should instruct patients to discontinue use and consult a doctor or dentist if symptoms persist or if the condition worsens after regular use. This guidance is crucial to ensure that patients receive appropriate care and to prevent any potential complications.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at room temperature, maintaining a range of 59°F to 86°F (15°C to 30°C).

Healthcare professionals should ensure that the product is not utilized if the safety seal is broken or missing, as this may compromise the integrity and safety of the product. Proper handling and adherence to these storage conditions are vital for maintaining the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)