Eye Drops

Description

NDC 46823-001-05 designates a sterile lubricant eye drop formulation. The product is packaged in two vials, each containing 0.17 fluid ounces (5 milliliters), resulting in a total net volume of 0.34 fluid ounces (10 milliliters).

Uses and Indications

This drug is indicated for use as a lubricant to prevent further irritation or to relieve dryness of the eye. It is also indicated for the temporary relief of discomfort associated with minor irritations of the eye or due to exposure to wind or sun.

Dosage and Administration

Healthcare professionals are advised to instill 1 or 2 drops of the medication in the affected eye(s) as needed. The frequency of administration should be determined based on the clinical condition of the patient and the response to treatment. It is important to ensure that the drops are administered in a sterile manner to prevent contamination.

Contraindications

Use of this product is contraindicated if the solution changes color or becomes cloudy, as this may indicate contamination or degradation of the product. Additionally, to prevent contamination, it is essential to avoid contact between the tip of the container and any surface during use.

Warnings and Precautions

For external use only. This product is contraindicated if the solution changes color or becomes cloudy, as this may indicate contamination or degradation.

When utilizing this product, it is imperative to avoid contamination. Users should refrain from touching the tip of the container to any surface to maintain sterility. After each use, the cap must be securely replaced to prevent exposure to environmental contaminants.

In the event of experiencing any of the following symptoms, it is crucial to discontinue use and consult a healthcare professional: eye pain, changes in vision, persistent redness or irritation of the eye, or if the condition worsens or does not improve within 72 hours.

Immediate medical assistance should be sought if the product is ingested. In such cases, contacting a Poison Control Center or seeking emergency medical help is essential.

Side Effects

Patients using this product should be aware of several important safety considerations. The product is intended for external use only. It is crucial to avoid using the solution if it changes color or becomes cloudy, as this may indicate contamination or degradation.

During use, patients are advised to take precautions to prevent contamination. Specifically, they should avoid touching the tip of the container to any surface and ensure that the cap is replaced immediately after use.

Patients should discontinue use and consult a doctor if they experience any of the following serious adverse reactions: eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Additionally, this product should be kept out of reach of children. In the event that the product is swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Eye Drops (glycerin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event that the product is swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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 this product during pregnancy provided in the drug insert. Additionally, there are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. As such, 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.

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 lactating mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be carefully considered.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack 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 relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific product and the amount ingested; therefore, a thorough assessment by a medical professional is recommended.

Management procedures will typically involve supportive care and symptomatic treatment, tailored to the individual case. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 the product is swallowed. It is important to instruct patients not to use the solution if there are any changes in color or if it becomes cloudy, as this may indicate a compromised product.

To prevent contamination, patients should be reminded not to touch the tip of the container to any surface. After each use, they should ensure that the cap is securely replaced to maintain the integrity of the product.

Patients should be informed to discontinue use and consult a doctor if they experience any of the following: eye pain, changes in vision, continued redness or irritation of the eye, or if their condition worsens or persists for more than 72 hours. This guidance is essential for ensuring patient safety and effective use of the product.

Storage and Handling

The product is supplied in a container that must be stored in a refrigerator, ensuring that it remains at a temperature range suitable for preservation. It is imperative to avoid freezing the product, as this may compromise its integrity. Additionally, the container should be kept in a dark, cool place, away from direct sunlight to maintain optimal conditions.

Once the container has been opened, it is essential to discard both the container and any remaining contents after 30 days to ensure safety and efficacy. Users should also be mindful to utilize the product before the expiration date indicated on the container to guarantee its effectiveness.

Additional Clinical Information

The medication is administered via the ophthalmic route, with a recommended dosage of 1 or 2 drops instilled in the affected eye(s) as needed. Clinicians should advise patients to remove contact lenses prior to instillation and to wait at least 10 minutes before reinserting them. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)