Super Mint Fluoride Mouthwash

Description

Super Mint Fluoride Mouthwash is a fluoride-based oral rinse formulated to enhance oral hygiene by targeting areas that traditional brushing and flossing may miss. This product is presented in a 16 fl oz (473 mL) volume and is manufactured by SuperMouth, located at 9737 Aero Drive, San Diego, CA 92123. For inquiries, the manufacturer 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 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. After swishing, the solution should be spat out. It is important to note that there is no need to rinse the mouth following the use of this product. 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. No other contraindications have been identified.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Pediatric Safety This product must be kept out of reach of children under 6 years of age to prevent accidental ingestion and potential harm.

Accidental Ingestion In the event that more than the recommended amount for rinsing is accidentally swallowed, it is imperative to seek medical assistance immediately or contact a Poison Control Center for guidance.

Product Integrity The product should not be used if the safety seal is broken. Utilizing a product with a compromised seal may pose safety risks and affect efficacy.

Side Effects

Patients should be advised to keep the product out of reach of children under 6 years of age. In the event that more than the recommended amount for rinsing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately. Additionally, the product should not be used if the safety seal is broken, as this may indicate potential contamination or compromised integrity.

These warnings highlight the importance of proper usage and safety precautions to prevent adverse reactions associated with misuse or accidental ingestion.

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 Super Mint 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 ingested, 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 Super Mint Fluoride Mouthwash in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as the absence of data necessitates careful consideration of individual patient factors. Monitoring for any adverse effects or unusual responses in this population is advisable, given the lack of established guidelines for geriatric use.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

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.

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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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.

In the event that more than the recommended amount is accidentally swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Additionally, it is important to inform 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.

For optimal storage, the product should be kept in a controlled environment, away from extreme temperatures and humidity. Specific temperature ranges and container requirements are not provided; however, general best practices for pharmaceutical storage should be followed to ensure product stability and efficacy. Special handling needs are not specified, but care should be taken to maintain the product's integrity throughout its storage and handling processes.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)