Ortho Super Vanilla Fluoride Mouthwash

Description

Ortho Super Vanilla Fluoride Mouthwash is a specialized fluoride mouthwash designed for orthodontic use. This unique formulation effectively reaches areas that brushing and flossing may miss, contributing to the prevention of bad breath. The product is presented in a 16 fl oz (473 mL) bottle. It is marketed under the brand name SuperMouth® and is manufactured by SuperMouth, located at 9737 Aero Drive, San Diego, CA 92123. For inquiries, the contact number is (844) MOUTHCARE.

Uses and Indications

Fluoride mouthwash is indicated for the prevention of dental caries and the reduction of bad breath by reaching areas that are not effectively cleaned by brushing and flossing. This product features a specialized formulation designed for patients with orthodontic appliances, ensuring comprehensive coverage of hard-to-reach areas.

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before each use. The recommended dosage is 10 mL, to be dispensed and used daily. Patients should swish the solution vigorously in the mouth for a duration of 1 minute before spitting it out. It is important to note that there is no need to rinse the mouth following the use of the product.

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 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 compromise of the product's integrity. Adhering to these precautions is essential to ensure safe usage and to mitigate any associated risks.

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 used 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 using the product.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and 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 Ortho 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 not have access to this product. In the event that more than the recommended amount for rinsing is accidentally ingested, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Geriatric Use

There is no specific information available 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

There is currently no information available regarding the use of Ortho Super Vanilla Fluoride Mouthwash during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Ortho Super Vanilla Fluoride Mouthwash in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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. It is important to inform patients that if more than the recommended amount 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 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 adhered to, particularly regarding the integrity of the safety seal.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)