Super Strawberry Fluoride Mouthwash

Description

Super Strawberry Fluoride Mouthwash is a product of the SuperMouth brand, available in a volume of 16 fluid ounces (473 mL). Manufactured by SuperMouth, located at 9737 Aero Drive, San Diego, CA 92123, this mouthwash is designed to access areas that brushing and flossing may not reach, contributing to the prevention of bad breath. For inquiries, contact can be made at (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 has no known teratogenic or nonteratogenic effects.

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 after spitting out the solution.

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 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 should not be used if the safety seal is broken, as this may indicate potential contamination or compromised integrity. Healthcare professionals are advised to ensure that patients are aware of these critical warnings to promote safe usage and prevent adverse events.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is crucial 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 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 precautions are essential to ensure the safe use of the product and to mitigate any risks associated with misuse or accidental exposure.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Super Strawberry 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

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

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 amount exceeding that which is typically used for rinsing is accidentally ingested, 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 risks associated with overdosage. Monitoring for symptoms related to the specific substance involved is essential, as these may vary based on the nature of the overdose.

Management procedures should include a thorough assessment of the patient's condition and the implementation of appropriate supportive care measures. It is advisable to follow established protocols for the treatment of overdoses, which may involve decontamination, symptomatic treatment, and monitoring of vital signs.

In summary, the key action in cases of overdosage is to ensure that medical help is sought immediately, thereby facilitating timely and effective management of the situation.

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 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 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 Strawberry Fluoride Mouthwash, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)