Perioe Microbiome Whitening

Description

PERIOE is a specialized toothpaste formulated to support oral health through the power of prebiotics, which help maintain a healthy balance of good bacteria in the microbiome. This product features a unique whitening agent that effectively removes stains, contributing to a brighter smile. The toothpaste is presented in a cool mint flavor, providing a refreshing taste. Each tube contains 116 grams (4.1 ounces) of the product.

Uses and Indications

This drug is indicated for the protection against dental cavities.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects reported.

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. It is important to ensure that the product is not swallowed. For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing, and caregivers should supervise the brushing process until proper oral hygiene habits are established.

For children under 2 years of age, it is recommended to consult a dentist for appropriate guidance on dental care and product use.

Contraindications

Use of this product is contraindicated in the following situations:

Swallowing the product is not advised. In the event of accidental ingestion beyond the amount used for brushing, seek professional assistance or contact a poison control center immediately.

Discontinue use immediately if an allergic reaction occurs.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings

This product should be kept out of reach of children under 6 years of age to prevent accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, it is crucial to seek professional assistance or contact a poison control center immediately.

Precautions

In the case of an allergic reaction, the use of this product must be discontinued immediately. Healthcare professionals should advise patients to monitor for any signs of an allergic response and to seek medical attention if such symptoms occur.

Emergency Medical Help Instructions

If accidental ingestion occurs, particularly in amounts exceeding the recommended usage for brushing, it is essential to seek professional medical assistance or contact a poison control center without delay.

Discontinuation Instructions

Patients should be instructed to stop using the product and consult their healthcare provider if they experience any allergic reactions. Prompt action is necessary to mitigate potential health risks.

Side Effects

Patients may experience adverse reactions during treatment. In the event of an allergic reaction, it is imperative to discontinue use immediately.

The safety profile of the treatment has been evaluated in clinical trials, where various adverse reactions were reported. Continuous monitoring for any signs of adverse effects is recommended to ensure patient safety.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be closely monitored when using this product. It is essential to keep the product out of reach of children, particularly those under 6 years of age. In the event of accidental swallowing of more than the amount used for brushing, immediate professional assistance or contact with a poison control center is advised.

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. To minimize the risk of swallowing, a pea-sized amount should be used for children under 6 years, and adult supervision is necessary until proper brushing habits are established.

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

Geriatric Use

There is no specific information available 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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of PERIOE Microbiome Whitening Cool Mint toothpaste during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential about 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 statements concerning 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 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 imperative that immediate action is taken. If the product is accidentally swallowed in quantities exceeding the amount typically used for brushing, healthcare professionals should advise patients to seek professional assistance without delay. Additionally, contacting a poison control center is strongly recommended to ensure appropriate management and guidance.

Symptoms of overdosage may vary, and prompt evaluation by a healthcare professional is essential to determine the necessary interventions. It is crucial to monitor the patient closely and provide supportive care as needed.

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 insert text.

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.

Patients should be informed not to swallow the product. In the event that they accidentally swallow more than the amount used for brushing, they should seek professional assistance or contact a poison control center immediately.

Additionally, healthcare providers should instruct patients to discontinue use immediately if any signs of an allergic reaction develop. It is important for patients to be aware of these potential risks and to take appropriate action if they occur.

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 route of administration for the product is dental. Clinicians should advise patients to keep the product out of reach of children, particularly those under 6 years of age. Patients should be instructed not to swallow the product. In the event of accidental ingestion of more than the amount used for brushing, it is crucial to seek professional assistance or contact a poison control center immediately. Additionally, if any allergic reaction occurs, patients should discontinue use right away.

Drug Information (PDF)

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

View product document (PDF)