Eversmile Alignerfresh Enamel Guard

Description

EverSmile® ALIGNERFRESH ENAMEL GUARD FLUORIDE FOAM is a dental product designed to enhance oral hygiene for users of orthodontic aligners. This formulation is presented in a 50 mL (1.69 fl oz) dosage form. It is manufactured by EverBrands, Inc., located at 401 N Oak St., Inglewood, CA 90302. For inquiries, the company can be contacted at 855 595-2999 or via email at info@eversmilewhite.com. Additional information is available on the official website at www.eversmilewhite.com.

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 12 years and older are instructed to apply the foam using the following method: dispense up to a full pump of foam inside each tray. The nozzle tip should be utilized to ensure that all areas of the tray are evenly covered with foam. After filling, the foam-filled trays should be placed back in the mouth, and any excess foam should be spat out. There is no requirement to rinse, as the foam naturally dissipates; however, it is important not to swallow the rinse.

For rinsing, adults and children aged 12 years and older should use the product twice daily, following brushing with toothpaste. They should vigorously swish 2 pumps of rinse between their teeth for 1 minute before spitting it out. It is crucial not to swallow the rinse and to refrain from eating or drinking for 30 minutes after rinsing. Children under 12 years of age should be instructed in proper rinsing techniques to minimize the risk of swallowing, and they should be supervised as necessary until they are capable of using the product without assistance. For children under 12 years of age, consultation with a dentist or doctor is recommended.

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.

Warnings and Precautions

Oral irritation or tooth sensitivity may occur during the use of this product. In such cases, it is imperative to discontinue use immediately and consult a dentist for further evaluation and management.

In the event of accidental ingestion of more than the recommended amount for rinsing, it is crucial to seek emergency medical assistance or contact a Poison Control Center without delay. Prompt action is essential to ensure safety and appropriate care.

Healthcare professionals should advise patients to remain vigilant for any adverse reactions and to stop using the product if any concerning symptoms arise. While no specific instructions for discontinuation were provided, it is advisable for patients to communicate with their healthcare provider regarding any unexpected effects.

Side Effects

Patients should be advised to discontinue use and consult a dentist if they experience oral irritation or tooth sensitivity. These reactions warrant immediate attention to prevent further complications.

In clinical trials and postmarketing experiences, the occurrence of these adverse reactions has been noted, emphasizing the importance of monitoring for any signs of discomfort in the oral cavity. It is crucial for patients to be aware of these potential reactions to ensure timely intervention and management.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Eversmile Alignerfresh Enamel Guard (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should be advised to consult a dentist or doctor prior to use. It is important to instruct these children in proper rinsing habits to minimize the risk of swallowing. Additionally, supervision is recommended for children until they are capable of using the product without assistance.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of EVERSMILE ALIGNERFRESH ENAMEL GUARD - sodium fluoride rinse in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on a nursing infant are not well studied; thus, the risks versus benefits should be considered.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved in the overdose.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose situation effectively.

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 provided text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if a patient accidentally swallows more than the recommended amount used for rinsing, they should seek medical assistance or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing potential adverse effects from misuse.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 68-77°F (20-25°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Eversmile Alignerfresh Enamel Guard, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)