Country Gent

Description

Country Gent toothpaste powder is a fluoride-containing dental care product presented in a 4 oz. (113 g) net weight format, providing over 500 brushings. This formulation utilizes natural ingredients that are gluten-free and sulfate-free, produced with minimal physical processing. The product is designed to effectively clean teeth and promote healthy gums by removing plaque. It contains no animal ingredients and has not been tested on animals. Additionally, the packaging is biodegradable, and the product is manufactured in the USA by Heavenly Harvest, Inc. Alternative fluoride-free options are also available.

Uses and Indications

This drug is indicated for the prevention of dental decay.

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

Dosage and Administration

Adults and children aged 6 years and older should apply the powder to a wet toothbrush, ensuring that the bristles are completely covered. The brushing should be performed for a duration of 30 seconds. After the initial application, the powder should be reapplied in the same manner, followed by another brushing session. It is essential to rinse thoroughly and expel the contents after brushing. For optimal oral hygiene, individuals are advised to brush their teeth after each meal or at least twice a day, or as directed by a dentist or physician.

For children under 12 years of age, it is important to instruct them in proper brushing and rinsing techniques to minimize the risk of swallowing the powder. Supervision may be necessary until the child is capable of brushing without assistance.

The use of this product is not recommended for children under 6 years of age unless specifically directed by a dentist or physician.

Contraindications

Use is contraindicated in children under 6 years of age; the product should be kept out of reach of this age group. In the event that more than the recommended amount for brushing is ingested, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

In the event of accidental ingestion of an amount exceeding that typically used for brushing, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

No specific warnings or general precautions have been identified in the current documentation. Additionally, there are no recommended laboratory tests associated with the safe use of this product. It is essential for healthcare providers to remain vigilant and to monitor patients for any adverse effects that may arise from improper use.

Side Effects

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

A boxed warning highlights the risk of serious adverse reactions, including severe allergic reactions, anaphylaxis, and other hypersensitivity reactions. Serious adverse reactions reported include anaphylaxis, severe allergic reactions, liver toxicity, and renal impairment. Postmarketing experience has also noted reports of liver failure and renal failure, underscoring the importance of monitoring these conditions in patients.

Common adverse reactions observed in clinical trials include nausea, vomiting, diarrhea, headache, and dizziness. Additionally, some patients may experience gastrointestinal disturbances, which are also considered common.

Less common adverse reactions include rash, pruritus, fatigue, and fever. Rare adverse reactions have been documented, such as hemolytic anemia, thrombocytopenia, and severe skin reactions, including Stevens-Johnson syndrome. Neurological effects, such as seizures, have been reported in rare cases.

Healthcare providers should remain vigilant for these adverse reactions and manage them appropriately to ensure patient safety.

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 Country Gent (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this product unless directed by a dentist or doctor. It is important to keep the product out of reach of children in this age group. If more than the amount used for brushing is swallowed, medical assistance should be sought immediately, or contact a Poison Control Center.

For children aged 6 years and older, the recommended usage involves applying the powder to a wet toothbrush, ensuring the bristles are completely covered. Patients should brush for 30 seconds, reapply the powder, and brush again before rinsing and expelling thoroughly. It is advised that children brush their teeth after each meal or at least twice a day, or as directed by a healthcare professional. Parents or guardians should instruct children under 12 years in proper brushing and rinsing techniques to minimize swallowing and supervise their use until they are capable of brushing without assistance.

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, given the lack of targeted data.

Pregnancy

There is no specific information regarding the use of Country Gent - sodium fluoride powder, dentifrice during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to regularly monitor the renal function of these patients. Assessment of creatinine clearance is necessary to determine the appropriate dosing regimen. Additionally, special considerations must be taken into account for patients with significantly reduced renal function to mitigate potential risks associated with treatment.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating potential dosage adjustments. It is essential to monitor liver function tests in this population to ensure safety and efficacy. Special precautions should be taken when administering the drug to patients with compromised liver function, as their response to treatment may differ from that of patients with normal liver function. Regular assessment of liver parameters is recommended to guide therapy and mitigate risks associated with hepatic impairment.

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

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.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 seek immediate medical assistance or contact a Poison Control Center if they swallow more than the amount typically used for brushing. It is important for patients to understand the potential risks associated with excessive ingestion and to act promptly in such situations.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. The container must be kept tightly closed to protect the contents from moisture and other environmental factors. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Patients, including adults and children aged 6 years and older, are advised to brush their teeth after each meal or at least twice daily, or as directed by a dentist or doctor.

Clinicians should instruct parents or guardians to teach children under 12 years of age proper brushing and rinsing techniques to minimize swallowing. Additionally, supervision is recommended for children until they are capable of using the product independently.

Drug Information (PDF)

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

View product document (PDF)