Otc - Active Ingredient
Active ingredients
Polyethylene glycol 400 0.4%
Propylene glycol 0.3%
Topcare Health Lubricant Eye Drops Solution
FDA Label NDC 36800-978
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Assoc Llc for the product Topcare Health Lubricant Eye Drops (NDC 36800-978). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, 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
Purpose
Polyethylene glycol 400.....Lubricant
Propylene glycol........Lubricant
Indications & Usage
Uses
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 product 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 the tip of container to any surface to avoid contamination
- replace cap after each use
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) gets worse or lasts 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
Dosage & Administration
Directions
- Instill 1 or 2 drops in the affected eye(s) as needed
- Children under 6 years of age: ask a doctor
Other Safety Information
Other information
- RETAIN THIS CARTON FOR FUTURE REFERENCE
- Store at room temperature
Inactive Ingredient
Inactive ingredients
Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride
* Please review the disclaimer below.
