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Glycerin

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Active ingredient
Glycerin 15 mg/3 mL
Other brand names
Drug class
Non-Standardized Chemical Allergen
Dosage form
Solution/ Drops
Route
Ophthalmic
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
March 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Glycerin 15 mg/3 mL
Other brand names
Drug class
Non-Standardized Chemical Allergen
Dosage form
Solution/ Drops
Route
Ophthalmic
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
March 20, 2025
Manufacturer
Regenerative Processing Plant, LLC
Registration number
M018
NDC root
82305-003
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to provide temporary relief from burning and irritation caused by dryness of the eye. It acts as a lubricant, helping to soothe and protect your eyes from further irritation while alleviating dryness. By creating a protective barrier, it helps maintain moisture and comfort in your eyes, making it easier for you to go about your day without discomfort.

Uses

If you're experiencing burning and irritation from dry eyes, this product can provide temporary relief. It acts as a lubricant, helping to soothe your eyes and prevent further irritation. Additionally, it serves as a protectant, ensuring that your eyes stay comfortable and hydrated. Whether you're dealing with dryness from environmental factors or prolonged screen time, this solution can help keep your eyes feeling better.

Dosage and Administration

To use this medication, you will need to instill 1 or 2 drops directly into the affected eye or eyes. You can do this as needed, depending on your symptoms. Make sure to follow any specific instructions provided by your healthcare provider for the best results.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away. There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication, but always use it responsibly and as directed.

Side Effects

If you experience eye pain, changes in vision, or ongoing redness and irritation of the eye while using this medication, it’s important to stop using it and consult your doctor. Additionally, if your condition worsens or does not improve within 72 hours, seek medical advice. These symptoms could indicate a more serious issue that needs attention.

Warnings and Precautions

This product is for external use only. To keep it safe and effective, avoid touching the tip of the container to any surface, and always replace the cap after use. If the solution changes color or becomes cloudy, do not use it.

You should stop using this product and consult your doctor if you experience eye pain, changes in vision, or if redness or irritation continues. If your condition worsens or does not improve within 72 hours, seek medical advice.

In case of accidental swallowing, it’s important to get emergency medical help or contact a Poison Control Center right away.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

In case of an emergency, contact your local poison control center or go to the nearest hospital. It's always better to be safe and get professional assistance if you think an overdose may have occurred. Remember, your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking any medication, including this one, you should consult with your healthcare provider to discuss potential risks and benefits tailored to your individual situation. Your health and the health of your baby are paramount, so always seek professional advice when it comes to medication during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it’s advisable to consult with your healthcare provider to discuss any potential risks or concerns related to your situation. They can help you make informed decisions about your health and your baby's well-being.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help right away or contact a Poison Control Center for assistance. Taking these precautions can help ensure your child's safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have about your liver condition and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the safety and effectiveness of your product, it's important to store it properly. Once you open the bottle, make sure to keep it in the refrigerator. This helps maintain the right conditions for the product to work as intended.

When handling the product, always be mindful of keeping it in a clean environment to avoid contamination. If you have any questions about disposal or further safety measures, please consult the product guidelines or your healthcare provider for more information.

Additional Information

If you have any questions about your medication, you can reach out for assistance at (800) 781-0818. This line is available to help you with any concerns or inquiries you may have.

Currently, there is no additional information available regarding laboratory tests, potential for abuse, administration methods, or postmarketing experiences related to this medication.

FAQ

What is the purpose of this eye drop?

This eye drop is for the temporary relief of burning and irritation due to dryness of the eye. It acts as a lubricant and protectant against further irritation.

How should I use this eye drop?

You should instill 1 or 2 drops in the affected eye(s) as needed.

Are there any warnings I should be aware of?

Yes, you should stop use and ask a doctor if you experience eye pain, changes in vision, or if the condition worsens or persists for more than 72 hours. It is for external use only.

What should I do if I swallow the eye drop?

If swallowed, get medical help or contact a Poison Control Center immediately.

How should I store this eye drop?

Store at refrigerated conditions once the bottle closure is activated to the open position.

Is there any specific information for children?

Yes, keep this product out of reach of children.

Are there any contraindications for this eye drop?

No specific contraindications are listed for this eye drop.

What should I do if the solution changes color or becomes cloudy?

If the solution changes color or becomes cloudy, do not use it.

Is there any information regarding use during pregnancy or nursing?

No specific information is provided regarding use during pregnancy or nursing.

Packaging Info

Below are the non-prescription pack sizes of Regener-Eyes. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Regener-Eyes.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Regener-Eyes is a sterile, preservative-free, isotonic solution that contains Sodium Hyaluronate at a concentration of 0.3% (3 mg/mL) as the active ingredient. The formulation includes the following inactive ingredients: Sodium Chloride, Sodium Phosphate, Potassium Phosphate, and Water for Injection. The pH of the solution is adjusted to approximately 7.2. Regener-Eyes appears as a clear, colorless to slightly yellow solution.

Uses and Indications

This drug is indicated for the temporary relief of burning and irritation due to dryness of the eye. It serves as a lubricant to prevent further irritation and to alleviate dryness of the eye. Additionally, it functions as a protectant against further irritation, providing relief from symptoms associated with dry eyes.

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 is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Warnings and Precautions

External use of this product is strictly advised. To prevent contamination, healthcare professionals should instruct patients not to touch the tip of the container to any surface and to ensure the cap is replaced immediately after use.

In the event that the solution changes color or becomes cloudy, it is imperative that the product is not used, as this may indicate a loss of efficacy or safety.

Patients should be advised to discontinue use and consult a physician if they experience any of the following symptoms: eye pain, changes in vision, persistent redness, or irritation of the eye. Additionally, if the condition worsens or does not improve within 72 hours, medical advice should be sought.

In cases of accidental ingestion, immediate medical assistance should be obtained, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if they experience any of the following serious adverse reactions: eye pain, changes in vision, continued redness, or irritation of the eye. Additionally, if the condition worsens or persists for more than 72 hours, medical advice should be sought. These warnings are critical for ensuring patient safety and prompt intervention in the event of serious ocular symptoms.

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 Regener-Eyes. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Regener-Eyes.
Details

Pediatric Use

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

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information 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 on the importance of effective contraception during treatment and should be informed of the absence of established safety data in pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should encourage patients to reach out with any questions or concerns regarding their treatment. Patients can contact the dedicated support line at (800) 781-0818 for assistance. It is important for healthcare providers to ensure that patients feel comfortable seeking clarification on their medication, potential side effects, and any other related inquiries.

Storage and Handling

The product is supplied in a configuration that includes a bottle with an activated closure. Once the bottle closure is opened, it must be stored under refrigerated conditions to maintain its integrity and efficacy. It is essential to adhere to these storage requirements to ensure optimal product performance.

Additional Clinical Information

Patients and clinicians may contact the provided helpline at (800) 781-0818 for any questions regarding the medication. No additional information is available concerning laboratory tests, abuse potential, administration routes, methods, frequency, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Regener-Eyes, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.