Emmi-Dent Whitening

Description

emmi® DENT WHITENING is an ultrasound toothpaste designed for effective dental care. It utilizes 100% ultrasound technology to enhance the whitening process. Manufactured in Germany, this product is developed by EMAG Germany, ensuring high-quality standards. The formulation is specifically tailored to work in conjunction with ultrasound devices for optimal results in oral hygiene.

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 2 years and older are advised to clean their teeth thoroughly after meals or at least twice daily, or as directed by a dentist. It is important to ensure that the product is not swallowed during use.

For children under 6 years of age, a pea-sized amount should be used to minimize the risk of swallowing. Caregivers should supervise the dental cleaning of children until proper habits are established to ensure effective use and safety.

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

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of more than the recommended amount for dental cleaning, 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 and potential harm.

In the event that more than the recommended amount used for dental cleaning is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be advised to keep this product out of reach of children under 6 years of age. In the event that more than the recommended amount for dental cleaning is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

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 Emmi-Dent Whitening (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should be supervised during dental cleaning to establish good habits and to ensure safety. It is recommended that a pea-sized amount of the product be used in children under 6 to minimize swallowing. For children aged 2 years and older, dental cleaning should be performed thoroughly after meals or at least twice a day, or as directed by a dentist.

Parents and caregivers should keep the product out of reach of children under 6 years. In the event that more than the recommended amount for dental cleaning is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised. For children under 2 years of age, consultation with a dentist 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

There is no information available regarding the use of Emmi-Dent Whitening (sodium fluoride paste, dentifrice) during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant patients, as the potential effects on fetal outcomes are not established. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There is no specific information regarding the use of Emmi-Dent Whitening (sodium fluoride paste, dentifrice) in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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, as the lack of data may impact the safety and efficacy of treatment in this population.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows an amount exceeding that which is typically used for dental cleaning, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware of the potential risks associated with overdosage and the importance of prompt intervention. Symptoms of overdosage may vary, and monitoring the patient closely for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. It is advisable to have the patient evaluated by a healthcare professional to determine the appropriate course of action based on the specific circumstances of the overdosage incident.

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 this product out of reach of children under 6 years of age to prevent accidental ingestion.

In the event that more than the recommended amount for dental cleaning is accidentally swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with improper use of the product.

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 product is administered via the dental route. For adults and children aged 2 years and older, it is recommended to clean teeth thoroughly after meals or at least twice a day, or as directed by a dentist. Patients should not swallow the product; to minimize swallowing in children under 6 years, a pea-sized amount should be used. It is advised that clinicians supervise children's dental cleaning until good habits are established. For children under 2 years, consultation with a dentist is recommended prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)