Evo Sensitive Whitening Anti-Cavity Fluoride Mouthwash

Uses and Indications

This drug is indicated for the protection of teeth 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 use the product daily, following the brushing of teeth with toothpaste. Prior to use, it is essential to rinse the mouth thoroughly to remove any residual toothpaste. The product should be shaken well before each use.

To administer, twist and remove the cap, then measure 15 ml of the rinse. The individual should rinse or gargle for a duration of 30 seconds before spitting it out. It is critical that the rinse is not swallowed. Additionally, individuals should refrain from eating or drinking for 30 minutes after rinsing. Supervision of children during this process is recommended to ensure proper use.

For children under 6 years of age, consultation with a dentist or doctor is required prior to use.

Contraindications

Use is contraindicated in children under 6 years of age. Due to the potential risk of accidental ingestion, if more than the recommended amount is swallowed, seek professional assistance or contact a Poison Control Center immediately.

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 of accidental ingestion of an amount exceeding that which is typically used for rinsing, it is crucial to seek professional medical assistance or contact a Poison Control Center immediately. Prompt action is essential to ensure the safety and well-being of the individual involved.

Side Effects

Patients should be aware of the potential risks associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age. In the event of accidental ingestion of more than the amount intended for rinsing, it is imperative to seek professional help or contact a Poison Control Center immediately.

This warning highlights the importance of proper usage and supervision to prevent serious adverse reactions in young children.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Evo Sensitive Whitening Anti-Cavity Fluoride Mouthwash (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not have access to this product, and caregivers are advised to keep it out of reach. In the event of accidental ingestion beyond the amount intended for rinsing, immediate professional assistance or contact with a Poison Control Center is recommended. For children in this age group, consultation with a dentist or doctor is essential 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 safety of this medication during pregnancy has not been established. There are no available data regarding its use in pregnant patients, and therefore, the potential risks to fetal outcomes remain unknown. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential. It is recommended that pregnant patients or those planning to become pregnant discuss the potential risks and benefits of treatment with their healthcare provider.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects during lactation. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication. It is recommended to monitor breastfed infants for any potential adverse effects if the medication is administered to a nursing mother.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 indicated 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, it is crucial for healthcare professionals to act promptly and effectively. If a patient accidentally ingests more than the recommended amount intended for rinsing, immediate action is required.

Recommended Actions Healthcare providers should advise the patient or caregiver to seek professional medical assistance without delay. Contacting a Poison Control Center is also strongly recommended to obtain specific guidance tailored to the situation.

Potential Symptoms While specific symptoms of overdosage may vary depending on the substance involved, it is essential to monitor the patient closely for any adverse reactions or unusual signs following the ingestion of excessive amounts.

Management Procedures Upon receiving the patient, healthcare professionals should conduct a thorough assessment and initiate appropriate management protocols based on the clinical presentation and guidance from the Poison Control Center. This may include supportive care and symptomatic treatment as necessary.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided 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. It is important to emphasize the potential risks associated with misuse. Instruct patients that if they accidentally swallow more than the amount intended for rinsing, they should seek professional help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and preventing adverse effects related to accidental ingestion.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Evo Sensitive Whitening Anti-Cavity Fluoride Mouthwash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)