Active Ingredients
Glycerin ................... 0.2%
Hypromellose ........... 0.2%
Polyethylene glycol 400 ......1%
Topcare Health Dry Eye Relief Eye Drops Solution
FDA Label NDC 36800-845
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 Associates Llc for the product Topcare Health Dry Eye Relief Eye Drops (NDC 36800-845). 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, purposes, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor if you experience, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Glycerin.......................Lubricant
Hypromellose..............Lubricant
Polyethylene glycol 400.........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
When Using This Product
- to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 to 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
Package Label.Principal Display Panel
Carton (Topcaredryeyerelief Cedlt0051tr2)
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