Active Ingredients
Glycerin 0.2%
Hypromellose 0.2%
Polyethylene glycol 400 1%
Artificial Tears Solution/ Drops
FDA Label NDC 68071-4555
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals,inc. for the product Artificial Tears (NDC 68071-4555). 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, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lubricant
Uses
- for protection against further irritation
- for temporary relief of burning and irritation due to dryness of the eye
Warnings
For external use only
Otc - Do Not Use
Do not use this product if solution changes color or becomes cloudy
Otc - When Using
When using this product
- to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
- remove contact lenses before using
Otc - Stop Use
Stop use and ask a doctor if you experience
- eye pain
- changes in vision
- continued redness or irritation of the eye, or if the condition worsens or persists 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.
Directions
- instill 1 or 2 drops in the affected eye(s) as needed
- children under 6 years of age: ask a doctor
Other Information
- store at 15°-30°C (59°-86°F)
Inactive Ingredients
benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic
Questions Or Comments?
1-800-540-3765
Package Label
Pdp (68071 4555 5)
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