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Regener-Eyes

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Active ingredient
Glycerin 12 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 12 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
82305-006
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 the discomfort associated with dryness. If you're experiencing these symptoms, this drug can be a helpful option to consider for maintaining eye comfort.

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 due to environmental factors or prolonged screen time, this solution can help keep your eyes feeling better.

Dosage and Administration

You should use this medication by instilling 1 to 2 drops in each eye, one to four times a day, or as directed by your eye care professional. This means you can apply the drops multiple times throughout the day to help manage your condition effectively.

If you find that your symptoms require additional relief, you can also instill 1 or 2 drops in the affected eye(s) as needed. Just remember to follow the guidance provided by your healthcare provider to ensure you’re using the medication safely and effectively.

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, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and as directed.

Side Effects

You should be aware that this medication is for external use only. To prevent contamination, avoid touching the tip of the bottle to any surfaces, including your skin or eyes. If the solution changes color or becomes cloudy, do not use it.

If you experience any eye pain, changes in vision, or ongoing redness and irritation, stop using the product and consult a doctor. Additionally, if your condition worsens or does not improve within 72 hours, seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or skin directly. To keep the solution clean, do not let the tip of the bottle touch any surfaces. If you notice that the solution has changed color or looks cloudy, do not use it.

You should stop using this product and contact your doctor if you experience any eye pain, changes in your vision, or if redness and irritation continue. If your condition worsens or does not improve within 72 hours, it's important to seek medical advice.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center right away. Your safety is a priority, so please take these precautions seriously.

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 overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts.

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 this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby.

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 immediate assistance. Always be vigilant to ensure that medications are stored safely to prevent any accidental ingestion.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness. If you notice any unusual side effects or changes in health, be sure to report these to your healthcare team promptly.

Renal Impairment

If you have kidney problems, 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's great to know that there are no reported drug interactions or interactions with laboratory tests for this medication. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or medications, as they can provide personalized advice tailored to your specific situation. Your safety and well-being are the top priority!

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its safety and effectiveness. Always follow any specific instructions provided with the product for optimal use.

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 drug indicated for?

The drug is indicated for the temporary relief of burning and irritation due to dryness of the eye.

How should I use this drug?

Instill 1 to 2 drops in each eye, one to four times per day, or as recommended by your eye care professional.

What should I do if I experience eye pain or changes in vision?

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness, or irritation of the eye.

What precautions should I take when using this drug?

This drug is for external use only. Avoid touching the tip of the bottle to any surface, including the eye or skin, and do not use if the solution changes color or becomes cloudy.

What should I do if the drug is swallowed?

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

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Is there any specific information for pregnant or nursing mothers?

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

How should I store this drug?

Store the drug at room temperature.

Who can I contact for questions about this drug?

You can call 800-781-0818 for any questions.

Packaging Info

Below are the non-prescription pack sizes of Regener-Eyes (glycerin). 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

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 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 to 2 drops in each eye, one to four times per day, or as recommended by the eye care professional. The dosing may be adjusted based on the patient's specific needs and response to treatment.

In cases where additional relief is required, 1 or 2 drops may be instilled in the affected eye(s) as needed. It is important to follow the prescribed regimen and consult with the eye care professional for any adjustments in dosage or frequency.

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, it is imperative that the tip of the bottle closure does not come into contact with any surfaces, including the eye or skin. The solution should not be used if there is any change in color or if it becomes cloudy, as this may indicate degradation of the product.

Healthcare professionals should instruct patients to discontinue use and seek medical advice 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 consultation is recommended.

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

Side Effects

Patients should be aware that the product is for external use only. To prevent contamination, it is crucial not to touch the tip of the bottle closure to any surfaces, including the eye or skin. The solution should not be used if it changes color or becomes cloudy.

In the event of experiencing eye pain, changes in vision, continued redness, or irritation of the eye, patients are advised to stop use and consult a doctor. Additionally, if the condition worsens or persists for more than 72 hours, medical advice should be sought.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. As such, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Regener-Eyes (glycerin). 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, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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, 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.

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. The effects on breastfed infants have not been established, and further research may be necessary to determine any implications for breastfeeding.

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 may be 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 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 initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consider contacting a poison control center for guidance on specific management protocols tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 by providing them with the contact number (800) 781-0818. It is important for patients to feel supported and informed throughout their healthcare journey.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

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, route, method, and frequency of administration, 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.