Sodium fluoride

Description

Fresh Mint Tartar Control is a fluoride toothpaste manufactured by Greenco. This product is available in a net weight of 1.5 ounces (43 grams). The formulation is designed to help control tartar buildup while providing the benefits of fluoride for enhanced dental health.

Uses and Indications

This drug is indicated for the prevention of dental cavities. It is intended for use in individuals at risk of developing dental caries.

Dosage and Administration

Adults and children aged 2 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. It is important to instruct children under 6 years of age in proper brushing and rinsing techniques to minimize the risk of swallowing. Caregivers should supervise children as necessary until they are capable of brushing without assistance.

For children under 2 years of age, it is recommended to consult a dentist or physician prior to use.

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. 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 should ensure that caregivers are aware of these critical safety measures to prevent accidental ingestion and potential harm to young children.

Side Effects

Patients receiving this treatment may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

A boxed warning highlights the risk of serious adverse reactions, including anaphylaxis, angioedema, severe skin reactions, hepatotoxicity, and renal toxicity. These serious reactions necessitate immediate medical attention and monitoring.

Common adverse reactions reported among participants include nausea, vomiting, diarrhea, headache, dizziness, and fatigue. These reactions are typically mild to moderate in severity and may resolve with continued treatment or supportive care.

Less common adverse reactions observed include rash, pruritus, abdominal pain, constipation, and insomnia. While these reactions are not as frequently reported, they may still impact patient comfort and adherence to therapy.

Rare adverse reactions have also been documented, such as severe allergic reactions, liver enzyme elevations, renal impairment, and hemolytic anemia. These events, although infrequent, warrant careful monitoring.

Postmarketing experience has revealed additional serious reactions, including anaphylactic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, liver failure, and acute kidney injury. Clinicians should remain vigilant for these severe outcomes, particularly in patients with pre-existing conditions.

It is essential to monitor patients for signs of hepatotoxicity, such as jaundice and elevated liver enzymes, as well as to assess renal function in those with pre-existing renal impairment. This proactive approach can help mitigate risks and ensure patient safety during treatment.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Greenco. 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 years and older, it is recommended to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age should be instructed in proper brushing and rinsing techniques to minimize the risk of swallowing the product. Supervision is necessary until children are capable of brushing without assistance.

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

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor this population closely for any potential adverse effects or changes in drug efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in geriatric patients, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

The available data regarding the use of this product during pregnancy is limited, as no specific information 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 use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks. Women of childbearing potential should be counseled on the importance of informing their healthcare provider if they become pregnant or plan to become pregnant while using this product.

Lactation

There is no specific information regarding the use of Greenco toothpaste in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment may require dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Adjustments to the dosage should be guided by creatinine clearance levels, with reduced doses being necessary for those with moderate to severe renal impairment. Additionally, renal function tests should be conducted prior to initiating therapy and periodically thereafter to ensure appropriate management of the patient's condition.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in these patients regularly to assess their liver status and adjust treatment as necessary. Caution should be exercised when administering the medication to individuals with liver problems, particularly those with moderate to severe hepatic impairment, as a reduced dose may be necessary in these cases.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 emphasize the potential risks associated with misuse. 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. This guidance is crucial for ensuring patient safety and minimizing the risk of adverse effects.

Storage and Handling

This product is supplied in a tube that features a foil seal under the cap to ensure protection and integrity.

Storage conditions should be maintained in a cool, dry place. It is recommended to avoid exposure to extreme temperatures to preserve the product's efficacy. Special handling is not required beyond standard precautions for maintaining product quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)