Dr. 9020 Dental Clinic

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, imprinted with "XYZ" on one side and "123" on the other. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The tablets are supplied in bottles containing 100 units.

Uses and Indications

This drug is indicated for oral use in individuals aged 6 years and older. The recommended administration involves a single daily dose of 10 mL, preferably taken before bedtime. Users should thoroughly brush their teeth prior to administration, mix the solution in the mouth for one minute, and then expectorate. To ensure optimal efficacy, it is advised that patients refrain from eating or drinking for 30 minutes following use.

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

Dosage and Administration

For dental use only, the dosage and administration of the medication should be determined based on the specific clinical situation and the patient's individual needs. Healthcare professionals are advised to follow established guidelines and protocols for dental applications.

The medication should be prepared and administered in accordance with the manufacturer's instructions, ensuring that all necessary precautions are taken to maintain sterility and efficacy.

It is essential to monitor the patient for any adverse reactions during and after administration, adjusting the dosage as necessary to achieve the desired therapeutic effect while minimizing potential side effects.

Healthcare professionals should ensure that patients are informed about the proper use of the medication and any relevant safety information.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Caution is advised regarding the fluoride content of this product, which is 90.5 ppm. It is imperative that this product not be used by individuals who are hypersensitive to any of its components.

When utilizing this product, it is essential to adhere to the following precautions: the product should not be swallowed, and it is not recommended for use in children under 6 years of age unless specifically directed by a dentist. Additionally, the product must be kept out of reach of children. In the event that a child ingests a significant amount of the product, it is advised to provide large quantities of milk and to follow the instructions of a healthcare professional.

Storage conditions are also critical for maintaining the product's integrity. The product should be stored in a cool place, away from direct sunlight, and in its original container to prevent misuse and preserve quality.

Overall, it is crucial to keep this product out of reach of children to ensure safety. No laboratory tests are required for the safe use of this product, and there are no specific emergency medical help instructions or directives to stop taking the product and contact a doctor.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The fluoride content of this product is 90.5 ppm, which necessitates caution in its use. It is contraindicated for individuals who are hypersensitive to any component of the formulation.

Additional precautions include the following: the product should not be swallowed, and it is not recommended for use in children under 6 years of age unless specifically instructed by a dentist. To ensure safety, the product must be kept out of reach of children. In the event of accidental ingestion, it is advised to provide large amounts of milk and seek medical guidance.

For optimal storage and to maintain product integrity, it should be kept away from direct sunlight and stored in a cool place. To prevent misuse and preserve quality, it is important not to change the container in which the product is stored.

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 Dr. 9020 Dental Clinic (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 specifically instructed by a dentist. It is important to keep this product out of reach of children to ensure safety.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

Lactating mothers should exercise caution when using this product due to the potential for excretion in breast milk. The effects on breastfed infants are not well studied; therefore, it is important to consider the risks versus benefits before use.

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, it is crucial to take immediate action to mitigate potential adverse effects. If a patient has ingested a significant quantity of the medication, it is recommended to administer large amounts of milk, as this may help to dilute the substance in the gastrointestinal tract.

Healthcare professionals should ensure that the patient follows the specific instructions provided by their physician regarding the management of overdosage. Monitoring for symptoms associated with overdosage is essential, although specific symptoms were not detailed in the provided information.

In all cases of suspected overdosage, it is advisable to contact a poison control center or seek emergency medical assistance to ensure appropriate management and care.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in a manner that ensures safety and quality. It is essential to keep the product out of the reach of children to prevent accidental ingestion. To maintain its integrity, the product should be stored in a cool place, away from direct sunlight. It is recommended to shade the light to further protect the product from potential degradation.

To prevent misuse and to preserve the quality of the product, it is crucial not to change the container. Adhering to these storage and handling guidelines will help ensure the product remains effective and safe for use.

Additional Clinical Information

Patients should administer the medication once daily, preferably before bedtime, after thoroughly brushing their teeth. For individuals aged 6 years and older, the recommended dosage is 10 ml, which should be mixed in the mouth for one minute before spitting it out. It is important for patients to refrain from eating or drinking for 30 minutes post-administration to ensure optimal effectiveness.

Clinicians should counsel patients to keep the medication out of reach of children and to avoid swallowing it. The product is not recommended for children under 6 years of age unless directed by a dentist. In cases of excessive ingestion, patients should be advised to consume large amounts of milk and follow their doctor's guidance. Additionally, the medication should be stored in a cool place away from direct sunlight, and the container should not be altered to prevent misuse and maintain product quality.

Drug Information (PDF)

This file contains official product information for Dr. 9020 Dental Clinic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)