Perioe Whitening Essentials

Description

PERIOE Whitening Essentials is a fluoride toothpaste formulated for cavity protection. It aids in the whitening of teeth by effectively removing surface stains. The product features a fresh aloe flavor combined with green mint, providing a refreshing taste experience. Each tube contains a net weight of 5.5 oz (156 g).

Uses and Indications

This drug is indicated for the protection against dental cavities.

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

Dosage and Administration

Adults and children aged 6 years and older are advised to brush their teeth thoroughly after each meal or at least twice a day, or as directed by a dentist or physician. It is important to ensure that the product is not swallowed.

For children between the ages of 6 and 12 years, a pea-sized amount of the product should be used to minimize the risk of swallowing. Caregivers should supervise the brushing and rinsing process until proper oral hygiene habits are established.

For children under the age of 6 years, it is recommended to consult a dentist or physician for appropriate guidance on usage.

Contraindications

Use of this product is contraindicated in individuals who may accidentally swallow it. In the event of accidental ingestion beyond the amount used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

It is imperative to keep this product out of the 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 swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Healthcare professionals should ensure that patients are aware of these critical warnings to promote safe usage and prevent potential health risks associated with accidental ingestion.

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 under 6 years of age. The product is not intended for swallowing; if more than the recommended amount used for brushing is accidentally ingested, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be at higher risk of adverse reactions if the product is misused.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach, as the product is not intended for this age group. It is important to note that the product should not be swallowed. In the event that more than the recommended amount for brushing is accidentally ingested, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 6 years and older, it is recommended to brush teeth thoroughly after each meal or at least twice daily, or as directed by a dentist or physician. To minimize the risk of swallowing, children between 6 and 12 years should use a pea-sized amount of the product and should be supervised during brushing and rinsing until proper oral hygiene habits are established. For children under 6 years, consultation with a dentist or physician 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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The available data regarding the use of this product during pregnancy is limited, as no specific information is provided in the drug insert. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns based on the available data.

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 an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the recommended amount used for brushing, 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 for symptoms may be necessary, although specific symptoms related to overdosage are not detailed in the provided information.

Management procedures should include supportive care and symptomatic treatment as required. It is essential to follow established protocols for handling cases of overdosage to ensure patient safety and effective care.

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 provided in the insert.

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. It is important to emphasize that the product is not intended to be swallowed. Instruct patients that if they accidentally swallow more than the amount used for brushing, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing potential adverse effects associated with misuse.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from freezing conditions. Once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)