Super Mint

Description

Supermouth super mint fluoride toothpaste is manufactured by SuperMouth® and is available in a net weight of 3.4 oz (96 g). The product is designed to provide effective dental care while ensuring safety. It is produced at the company's facility located at 9737 Aero Drive, San Diego, CA 92123. For inquiries, the manufacturer can be contacted at (844) MOUTHCARE.

Uses and Indications

This drug is indicated for the prevention of cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For children under 3 years of age, a dosage of no more than a tiny grain-of-rice smear is recommended. For children between 3 and 6 years, a pea-sized amount should be used.

The product should be applied to a SuperMouth® toothbrush, and teeth should be brushed thoroughly for at least 2 minutes, twice daily, or as directed by a Dentist or Physician. It is essential that caregivers supervise the child during brushing and rinsing to minimize the risk of swallowing the product.

Contraindications

Use is contraindicated in children under 6 years of age due to the risk of accidental ingestion. In the event of accidental swallowing of an amount greater than that used for brushing, immediate medical assistance or contact with a Poison Control Center is advised.

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 used for brushing is accidentally swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Healthcare professionals are reminded to emphasize the importance of adhering strictly to the product label instructions. This ensures safe and effective use, minimizing the risk of adverse effects associated with misuse.

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 brushing is accidentally swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Super Mint (super mint toothpaste). 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 the product. In the event that more than the recommended amount for brushing is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

For children under 3 years, the product should be used in a quantity no greater than a tiny grain-of-rice smear. For children aged 3 to 6 years, a pea-sized amount is recommended. It is important to place the product on a SuperMouth® toothbrush and ensure that teeth are brushed thoroughly for at least 2 minutes, twice a day, or as directed by a Dentist or Physician. Caregivers should supervise the child’s brushing and rinsing to minimize the risk of swallowing.

Geriatric Use

There is no specific information 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 no specific information regarding the use of Super Mint Fluoride Toothpaste during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential about the use of this product during pregnancy. It is recommended that pregnant patients consult their healthcare provider for personalized guidance.

Lactation

There is no specific information regarding the use of Super Mint Fluoride Toothpaste in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the absence of data when advising lactating mothers about the use of this product. The effects on breastfed infants have not been established.

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, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information readily available to assist medical personnel in determining the appropriate course of action.

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 this product out of the reach of children under 6 years of age to prevent accidental ingestion. It is important to emphasize that if more than the recommended amount used for brushing is accidentally swallowed, patients should seek medical help or contact a Poison Control Center immediately. Additionally, patients should be reminded to always follow the instructions provided on the label to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in accordance with the specifications outlined on the label. It is essential to adhere to the provided instructions for optimal handling and storage.

Storage conditions require maintaining the product within the specified temperature range as indicated on the label. Proper container requirements must be observed to ensure the integrity of the product. Special handling needs should also be followed as per the labeling instructions to guarantee safety and efficacy.

Healthcare professionals are advised to consult the label for detailed information regarding NDC numbers and packaging configurations.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)