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| Product NDC Code | 82305-006 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Regener-eyes lite |
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| Type | Brand | ||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | OPHTHALMIC | ||||||
| Dosage Form | SOLUTION/ DROPS | ||||||
| RxCUI drug identifier | 2610311, 2610313 |
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| Application Number | M018 | ||||||
| Labeler Name | Regenerative Processing Plant, LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Glycerin 0.4%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Directions Instill 1 to 2 drops, one to four times per day in each eye, or as recommended by your eye care professional. Instill 1 or 2 drops in the affected eye(s) as needed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Sterile Water, Tonicity Solution Sodium Chloride.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary relief of burning and irritation due to dryness of the eye. For use as a lubricant to prevent further irritation or to relieve dryness of the eye. For use as a protectant against further irritation or to relieve dryness of the eye.
Purpose
Information about the drug product’s indications for use.Eye Lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Regener-Eyes LITE Glycerin GLYCERIN GLYCERIN WATER SODIUM CHLORIDE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Artwork 82305-006-01 Box Artwork 82305-006-02 Box Artwork Regener-Eyes LITE ophthalmic Solution Primary Label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Instill 1 or 2 drops in the affected eye(s) as needed.
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Questions? Questions? (800) 781-0818
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children Keep out of reach of children . If swallowed, get medical help, or contact a Poison Control Center immediately.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.Other information Store at Room Temperature.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Warnings External Use Only To avoid contamination, do not touch tip of the bottle closure to any surface(s) including the eye or the skin. Do not use if solution changes color or becomes cloudy. Stop use and ask a doctor If You experience eye pain, changes in vision, continued redness, or irritation of the eye. Condition worsens or persists for more than 72 hours.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API