Freshmint Anticavity Fluoride Gel Toothpaste

Description

freshmint® is an anticavity fluoride gel toothpaste formulated to help prevent dental caries. The product is packaged in a net weight of 6.4 ounces (181 grams).

Uses and Indications

ANTICAVITY FLUORIDE GEL TOOTHPASTE is indicated for the prevention of dental caries (cavities).

There are no teratogenic or nonteratogenic effects associated with this product.

Dosage and Administration

Adults and children aged 6 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician. For children aged 2 to 6 years, a pea-sized amount of the product should be used, and caregivers must supervise the child's brushing and rinsing to minimize the risk of swallowing. For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

The product is intended for dental use, and the method of administration involves brushing the teeth. It is recommended that brushing occurs preferably after each meal or at least twice a day to ensure optimal oral hygiene.

Contraindications

Use is contraindicated in children under 6 years of age due to the potential 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 and potential harm.

In the event that more than the recommended amount used for brushing 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 and intervention.

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. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative 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

No drug interactions have been identified for the product, indicating that it does not exhibit significant pharmacokinetic or pharmacodynamic interactions with other medications. Additionally, there are no known interactions with laboratory tests associated with this product. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Freshmint Anticavity Fluoride Gel Toothpaste (fluoride 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 aged 2 to 6 years, it is recommended to use only a pea-sized amount of the product. Caregivers should supervise the child's brushing and rinsing to minimize the risk of swallowing.

For infants and children under 2 years of age, consultation with a dentist or physician is necessary prior to use.

Geriatric Use

There is no specific information regarding the use of FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise clinical judgment when considering the use of this product in elderly patients, as individual patient factors may influence safety and efficacy. Monitoring for any adverse effects or changes in oral health status is advisable when administering this product to geriatric patients.

Pregnancy

There is no specific information regarding the use of FRESHMINT ANTICAVITY FLUORIDE GEL TOOTHPASTE during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, 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 the benefits and risks be evaluated on a case-by-case basis, taking into account the overall oral health needs of the patient.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the potential risks to breastfed infants are not well characterized. It is advisable to consider the benefits of breastfeeding alongside the potential risks associated with the 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, 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 adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to provide the patient with information regarding the amount ingested and the time of ingestion to facilitate appropriate medical response.

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. Instruct patients that if more than the recommended amount used for brushing is accidentally swallowed, they should seek medical help or contact a Poison Control Center immediately.

For adults and children aged 6 years and older, it is important to emphasize the necessity of brushing teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

For children aged 2 to 6 years, healthcare providers should recommend using only a pea-sized amount of the product and supervising the child's brushing and rinsing to minimize the risk of swallowing.

Additionally, for children under 2 years of age, it is essential to advise patients to consult a dentist or physician before use.

Storage and Handling

The product is supplied in packaging that ensures its integrity and efficacy. It should be stored at room temperature, away from direct light exposure to maintain its quality. It is imperative to avoid freezing the product, as this may compromise its effectiveness. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is dental. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Freshmint Anticavity Fluoride Gel Toothpaste, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)