Otc - Active Ingredient
Drug Facts
Active ingredients Purpose
Polyethylene Glycol 400 0.4%....................... Eye lubricant
Propylene Glycol 0.3%....................................Eye lubricant
Family Care Ultra Lubricant
FDA Label NDC 65923-588
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 Ultra Lubricant (NDC 65923-588). 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
Uses
- for the temporary relief of burning and irritation due to:
- dryness of the eyes
- exposure to wind or sun
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- if this product changes color or becomes cloudy
- if you are sensitive to any ingredient is this product
Otc - When Using
When using this product
- remove contact lenses before use
- replace cap after each use
- do not touch tip of bottle to any surface to avoid contamination
Otc - Stop Use
Stop use and ask a doctor if
- you experience eye pain and/or vision change
- you continue to have eye redness and/or irritation
- irritation, burning persists or worsens for 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
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, boric acid, hypromellose, hydrochloric acid, potassium chloride, purified water, sodium chloride, sodium hydroxide
Dosage & Administration
Distributed by:
United Exchange Corp,
Cypress, CA 90630 USA
1-888-645-8204
Made in South Korea
Package Label.Principal Display Panel
588 (588.1)
* Please review the disclaimer below.
