Otc - Active Ingredient
Active ingredients Purpose
Polyvinyl alcohol 0.5%....................................Lubricant
Povidone 0.6%..............................................Lubricant
Family Care Artificial Eye
FDA Label NDC 65923-512
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Artificial Eye (NDC 65923-512). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- For the temporary relief of burning & irritation due to dryness of the eye
- For use as a protectant against further irritation or to relieve dryness of the eye
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use
- if solution changes color or becomes cloudy.
Otc - When Using
When using this product
- to avoid contamination, do not touch tip to any surface
- replace cap after using
Otc - Stop Use
Stop use and ask a doctor if
- you experience eye pain
- you experience changes in vision
- you experience continued redness or irritation of the eye
- the condition worsens
- symptoms last for more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Directions
- Instill 1 or 2 drops in the affected eye(s) as needed.
Storage And Handling
Other information
- store at room temperature
- remove contact lenses before using
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, dibasic sodium phosphate hydrate, edetate disodium, glucose, hydrochloric acid, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate hydrate, sodium hydroxide
Dosage & Administration
Distributed by:
United Exchange Corp.
17211 Valley View Ave.
Cerritos, CA 90703 U.S.A.
Toll Free: 1 800 814 8028
Made in Korea
Package Label.Principal Display Panel
Image Description (512)
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