Super Vanilla Fluoride Mouthwash

Description

Supermouth is a fluoride mouthwash formulated to effectively reach areas that brushing and flossing may miss, thereby preventing bad breath. The product is presented in a dosage form of a liquid mouthwash, available in a 16 fl oz (473 mL) container. It is marketed under the brand name SuperMouth® and features a super vanilla flavor. The manufacturer is located at 9737 Aero Drive, San Diego, CA 92123, and can be contacted at (844) MOUTHCARE.

Uses and Indications

Fluoride mouthwash is indicated for the prevention of dental caries and the maintenance of oral hygiene by reaching areas that brushing and flossing may not effectively clean. Additionally, it aids in the prevention of bad breath.

There are no teratogenic or nonteratogenic effects associated with the use of this product.

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before each use. The recommended dosage is 10 mL, which should be dispensed and swished vigorously in the mouth for a duration of 1 minute. Following this, the patient should spit out the solution. It is important to note that there is no need to rinse the mouth after spitting out the solution. This administration should be performed daily to ensure optimal efficacy.

Contraindications

Use is contraindicated if the safety seal is broken, as this may compromise the integrity and safety of the product.

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 rinsing is accidentally swallowed, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

The product must not be used if the safety seal is broken, as this may indicate potential contamination or compromised integrity. Ensuring the safety seal is intact prior to use is crucial for maintaining the product's efficacy and safety profile.

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 to prevent accidental ingestion. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Additionally, the product should not be used if the safety seal is broken, as this may indicate potential contamination or compromised integrity.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond the outlined warnings. However, it is essential for patients to adhere to the usage instructions to minimize any risk of adverse effects.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Super Vanilla Fluoride Mouthwash (anticavity mouthwash). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should be kept out of reach of this product. In the event that more than the recommended amount for rinsing is accidentally swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. 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 advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 amount intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

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 provided in the insert for Super Vanilla Fluoride Mouthwash (SPL code 90375-7).

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

Additionally, healthcare providers should instruct patients not to use the product if the safety seal is broken, as this may indicate that the product is compromised and could pose a risk to their health.

Storage and Handling

The product is supplied in packaging that includes a safety seal. It is imperative that the product not be used if the safety seal is broken, as this may compromise the integrity and safety of the product.

Storage conditions should be monitored closely to ensure optimal product stability. Specific temperature ranges and container requirements are not provided; however, general best practices for storage should be followed. Special handling needs may apply, and healthcare professionals are advised to adhere to any additional guidelines provided by the manufacturer.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Super Vanilla Fluoride Mouthwash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)