Dr Dental Care 250ml

Description

This product is identified by the code 51945-4 and is associated with the package label principal display panel. The effective date of this labeling is September 29, 2014. The product is presented in a carton, which is depicted in an accompanying image file named "dr dental care 250ml carton.jpg." The carton is designed to contain a total volume of 250 mL.

Uses and Indications

This drug is indicated for use as a mouthwash with outstanding oral disease prevention effects.

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to rinse their mouth with 10-15 mL of the solution for a duration of 30 seconds. This procedure should be performed as directed to ensure optimal efficacy and safety.

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

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Children under the age of 6 should not have access to this product. It is essential to store the product in a location that is out of reach of children to prevent accidental ingestion.

The product should be kept away from direct sunlight and stored at room temperature to maintain its efficacy. After each use, the lid must be securely closed to prevent contamination and preserve the integrity of the product.

Prior to use, individuals should consult a healthcare professional if they have known allergies to any of the ingredients contained in the formulation. In the event of accidental ingestion of a significant amount of the product, it is crucial to drink a large quantity of milk and seek immediate medical assistance.

No specific instructions for discontinuation of use or general precautions have been provided in the insert. Additionally, there are no recommended laboratory tests associated with the safe use of this product.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years old to prevent accidental ingestion. Additionally, patients are advised to avoid direct sunlight exposure and to store the product at room temperature. After each use, the lid should be securely closed to maintain product integrity.

Before using this product, individuals should consult a healthcare professional if they have known allergies to any of the ingredients. In the event that a significant amount of the product is accidentally swallowed, it is recommended to drink a large amount of milk and seek medical assistance promptly.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Dr Dental Care 250ml (sodium fluoride). 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 this medication. In the event of accidental ingestion of a significant amount, it is advised to drink a large amount of milk and seek medical assistance promptly.

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 currently no information available regarding the use of DR DENTAL CARE 250ML - sodium fluoride liquid during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution and consider the lack of data when prescribing this product to women of childbearing potential. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There is no specific information regarding the use of DR DENTAL CARE 250ML - sodium fluoride liquid in lactating mothers or lactation considerations. Consequently, healthcare professionals should exercise caution when recommending this product to nursing mothers, as the effects on breastfed infants have not been established.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, if a significant amount of the product is accidentally ingested, it is crucial to take immediate action. The individual should drink a large quantity of milk to help mitigate the effects of the overdose. Following this, it is imperative to seek medical assistance promptly to ensure appropriate evaluation and management.

Healthcare professionals should be aware of the potential symptoms that may arise from an overdosage, although specific symptoms are not detailed in the provided information. Therefore, monitoring the patient for any adverse reactions is essential.

Management of an overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended, and further interventions may be required based on clinical judgment and the severity of the symptoms presented.

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. In the event that a significant amount is accidentally swallowed, patients should be instructed to drink a large amount of milk and seek medical assistance immediately. It is important for patients to understand the potential risks associated with accidental ingestion and the appropriate steps to take in such situations.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product at room temperature, away from direct sunlight, to maintain its efficacy. After each use, the lid must be securely closed to prevent contamination and preserve the product's quality.

Additional Clinical Information

The product is administered topically, with specific directions for use: patients should rinse their mouth with 10-15 ml of the solution for 30 seconds. 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 Dr Dental Care 250ml, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)