Perioe Whitening Essentials

Description

Whitening Essentials 10X is a fluoride toothpaste formulated for cavity protection and enhanced whitening. It contains 10 times more charcoal than Whitening Essentials Charcoal Fresh Mint Toothpaste, effectively aiding in the removal of surface stains to help whiten teeth. The product is presented in a black formulation with a clean mint flavor. Each tube contains a net weight of 0.7 oz (20 g).

Uses and Indications

This drug is indicated for the protection against cavities.

There are no teratogenic effects associated with this drug. Additionally, 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 daily, 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

The product should not be swallowed. In the event that more than the recommended amount for brushing is accidentally ingested, seek medical assistance or contact a Poison Control Center immediately. Additionally, if an allergic reaction occurs, discontinue use without delay.

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 accidentally swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should be vigilant for signs of allergic reactions. Should any allergic reaction occur, the use of the product must be discontinued immediately to mitigate potential adverse effects.

Side Effects

In clinical use, patients may experience adverse reactions that necessitate careful monitoring. Should an allergic reaction occur, it is imperative to discontinue use immediately to prevent further complications.

Additionally, it is crucial 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, patients should seek medical assistance or contact a Poison Control Center without delay.

Drug Interactions

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

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 should be kept out of reach of children under 6 years of age. For children between 6 and 12 years, it is recommended to use a pea-sized amount to minimize swallowing, and caregivers should supervise brushing and rinsing until proper oral hygiene habits are established. For children under 6 years, consultation with a dentist or physician is advised. In case of accidental swallowing of more than the amount used for brushing, medical assistance or contact with a Poison Control Center is necessary.

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 different pharmacokinetic and pharmacodynamic responses compared to younger populations. Monitoring for efficacy and adverse effects is recommended in this demographic, given the lack of targeted data.

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 use 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 regarding lactation.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows an amount exceeding that typically 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 this overdosage scenario are not detailed in the provided information.

Management of overdosage should focus on 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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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. Instruct them that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately.

Additionally, healthcare providers should counsel patients to discontinue use immediately if they experience any signs of an allergic reaction. It is important for patients to be aware of these potential reactions and to seek appropriate medical attention 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 maintain safety and efficacy.

Additional Clinical Information

No further data are available.

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)