Active Ingredient
Glycerin, 0.5%
Regener-eyes
FDA Label NDC 82305-003
11 label sections · Submitted to the FDA by Regenerative Processing Plant, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Regenerative Processing Plant, Llc for the product Regener-eyes (NDC 82305-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children, directions, recent major changes, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Eye Lubricant
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.
Warnings
External Use Only
- To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
- If solution changes color or becomes cloudy, do not use.
- You experience eye pain, changes in vision, continued redness, or irritation of the eye.
- Condition worsens or persists for more than 72 hours.
Stop use and ask a doctor If
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center immediately.
Directions
Instill 1 or 2 drops in the affected eye(s) as needed.
Recent Major Changes
Instill 1 or 2 drops in the affected eye(s) as needed.
Inactive Ingredients
Sterile Water, Tonicity Solution Sodium Chloride
Other Information
- Store at refrigerated conditions once the bottle closure is activated to the open position.
Questions?
Questions? (800) 781-0818
Artwork
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