Ortho Super Chocolate Fluoride Mouthwash

Description

Ortho Super Chocolate Fluoride Mouthwash is a specialized fluoride mouthwash designed for orthodontic care. This unique formulation, branded as Supermouth, incorporates hydroxamin® to enhance its efficacy. It is specifically engineered to reach areas that traditional brushing and flossing may miss, providing comprehensive oral hygiene support for individuals with braces. The product is available in a 16 fl oz (473 mL) bottle and features a super chocolate flavor.

Uses and Indications

Fluoride mouthwash is indicated for use in orthodontics to effectively reach areas that brushing and flossing may not adequately clean.

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, 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. No other contraindications have been specified.

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 should 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 or contact a Poison Control Center immediately. Prompt action is crucial to ensure patient safety.

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

Healthcare professionals are encouraged to monitor patients for any adverse reactions and ensure that proper usage guidelines are followed to mitigate risks associated with this product.

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 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 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, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

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

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 provided in the insert for Ortho Super Chocolate 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.

Instruct 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, inform patients not to use the product if the safety seal is broken, as this may indicate that the product is compromised.

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 direct sunlight and moisture. Specific temperature ranges for storage are not provided; however, it is advisable to maintain standard room temperature conditions to ensure product stability.

Care should be taken to handle the product gently to avoid any damage to the packaging or the product itself.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)