Otc - Active Ingredient
Active ingredients Purpose
Polyethylene glycol 400 0.4%...............................Eye lubricant
Propylene glycol 0.3%.........................................Eye lubricant
Family Care Lubricant Eye
FDA Label NDC 65923-580
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 Lubricant Eye (NDC 65923-580). 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 - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use
- for the temporary relief of burning and irritation due to dryness of the eye
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- if this solution changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
Otc - When Using
When using this product
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
- remove contact lense before using
Otc - Stop Use
Stop use and ask a doctor if
- you feel eye pain
- changes in vision occur
- redness or irritation of the eye(s) lasts
- condition worsens or lasts more than 72 hours
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
- shake well before using
- instill 1 or 2 drops in the affected eye(s) as needed
- children under 6 years of age: ask a doctor
Storage And Handling
Other information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
boric acid, calcium chloride, chlorhexidine gluconate, hydrochloric acid, hypromellose, magnesium chloride, potassium chloride, purified water,
sodium chloride, sodium hydroxide, zinc chloride
Dosage & Administration
Distributed by:
United Exchange Corp.
17211 Valley View Ave.
Cerritos, CA 90703 U.S.A.
Made in Korea
Package Label.Principal Display Panel
Image Description (580.1)
* Please review the disclaimer below.
