Super Chocolate Fluoride Mouthwash

Description

Super Chocolate Fluoride Mouthwash is a fluoride-containing oral rinse formulated to promote dental health. This product is marketed under the brand name SuperMouth and is presented in a dosage form of a mouthwash. Each bottle contains 16 fluid ounces (473 mL) of the solution, which features a super chocolate flavor. Super Chocolate Fluoride Mouthwash is manufactured by SuperMouth® and is distributed from their facility located at 9737 Aero Drive, San Diego, CA 92123. For inquiries, the contact number is (844) MOUTHCARE.

Uses and Indications

This drug is indicated for use as a fluoride mouthwash. It is designed to aid in the prevention of dental caries by providing topical fluoride to the oral cavity.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

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 efficacy 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 and potential harm.

In the event that more than the recommended amount for rinsing 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 of the situation.

The product should not be used if the safety seal is broken, as this may indicate potential contamination or compromised integrity, which could pose risks to patient safety.

No specific instructions for discontinuation of use and consultation with a healthcare provider are provided in the insert; however, practitioners should exercise clinical judgment in the context of individual patient circumstances.

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, it is crucial 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 precautions are essential to ensure the safety and well-being of patients and to mitigate any risks associated with improper use.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Super Chocolate 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

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Consequently, the effects on breastfed infants and the excretion of the drug in human milk remain undetermined. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

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 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 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 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.

Instruct 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, 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.

Storage conditions should be monitored to ensure optimal preservation. Specific temperature ranges and container requirements are not provided; however, general best practices for storage should be followed to maintain product efficacy. Special handling needs should be observed to prevent any damage or contamination.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)