2080 K Original

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider this information when evaluating treatment options for their patients.

Dosage and Administration

The toothpaste contains 1,000 ppm fluoride, which is intended for use in the prevention of dental caries. It is recommended that healthcare professionals advise patients to use a pea-sized amount of toothpaste for each brushing session.

Patients should be instructed to brush their teeth at least twice daily, preferably in the morning and before bedtime. It is important to ensure that patients do not swallow the toothpaste and to supervise children during brushing to minimize ingestion.

For optimal results, patients should be encouraged to avoid rinsing their mouths immediately after brushing to allow the fluoride to remain in contact with the teeth for a longer duration. Regular dental check-ups should be scheduled to monitor oral health and the effectiveness of fluoride treatment.

Contraindications

Use of this product is contraindicated in individuals who experience irritation to the gums, teeth, or oral mucosa.

Warnings and Precautions

The use of this product is strictly limited to the indications specified on the label. Any deviation from these intended uses is not recommended. In the event of eye contact, it is imperative to rinse the affected area immediately with water. Should irritation persist following rinsing, medical assistance must be sought without delay.

Healthcare professionals should advise patients to discontinue use and consult their dentist if any irritation occurs in the gums, teeth, or oral mucosa. This precaution is essential to prevent further complications and ensure patient safety.

No specific emergency medical assistance instructions are provided; however, it is advisable for healthcare providers to remain vigilant and prepared to address any adverse reactions that may arise during the use of this product.

Currently, there are no additional general precautions or laboratory tests specified for monitoring the safe use of this product. It is recommended that healthcare professionals remain attentive to any emerging safety information or guidelines related to its use.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur if the product is used for purposes other than those described on the label. In the event of eye contact, it is imperative to rinse the affected area immediately with water. Should irritation persist, medical assistance should be sought.

Common adverse reactions include irritation to the gums, teeth, or oral mucosa. Patients are advised to discontinue use and consult their dentist if such irritation occurs. It is essential for patients to follow the instructions provided to minimize the risk of adverse effects.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

Below are the non-prescription pack sizes of 2080 K Original (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 to prevent accidental ingestion. For this age group, it is recommended to use a pea-sized amount of the product to minimize the risk of swallowing. Caregivers should supervise brushing until proper oral hygiene habits are established. In the event that a child swallows more than the amount intended for brushing, it is crucial to seek professional assistance or contact a Poison Control Center immediately.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data in pregnancy.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this 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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up 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 this product out of the reach of children under 6 years of age to prevent accidental ingestion or misuse.

Patients should be informed to discontinue use and consult their dentist if they experience any irritation to the gums, teeth, or oral mucosa. It is important for patients to understand the significance of these symptoms and the necessity of seeking professional advice to ensure their oral health is not compromised.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered via the dental route. Clinicians should counsel patients to use the product solely for its intended purposes as described on the label. In the event of eye contact, patients should rinse immediately with water and seek medical assistance if irritation persists. It is essential to keep the product out of reach of children under 6 years of age. Patients should discontinue use and consult their dentist if they experience irritation to the gums, teeth, or oral mucosa.

Patients are advised not to swallow the product and to rinse their mouths with water after brushing. For children under 6 years, a pea-sized amount should be used to minimize swallowing, and brushing should be supervised until proper habits are established. If a child swallows more than the amount used for brushing, professional assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for 2080 K Original, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)