Active Ingredients
Light Mineral Oil (0.5)................................Emollient
Mineral Oil (0.5%).....................................Emollient
Retaine Mgd Emulsion
FDA Label NDC 54799-917
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ocusoft Llc for the product Retaine Mgd (NDC 54799-917). 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 ingredients, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of the reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For use as a protectant against further irritation or to relieve dryness of the eye.
Warnings
For use in the eyes only.
Do Not Use
- if this product changes color.
When Using This Product
- do not touch tip of container to any surface to avoid contamination.
- do not reuse once opened.
Stop Use And Ask A Doctor If
- you feel eye pain or changes in vision, continued redness or irritation of the eye.
- the condition worsens or persists for more than 72 hours.
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- Shake well before using.
- Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
Other Information
- Use only if printed tamper seals on top and bottom flaps are intact.
- Drops appear as a milky white solution.
- Store between 15 o-30 oC (59 o-86 oF).
Inactive Ingredients
Cetalkonium chloride, glycerol, poloxamer 188, tris hydrochloride, tromethamine, tyloxapol, water for injection.
Questions?
Call (800)233-5469 M-F 8:30AM-5:00PM CST or visit www.retainebrand.com
Otc - Purpose
Emollient
* Please review the disclaimer below.
