Warnings
Warnings for External use only.
Hydropure Lubricating Eye Drops Solution/ Drops
FDA Label NDC 84227-851
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ote North America for the product Hydropure Lubricating Eye Drops (NDC 84227-851). 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 warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, otc - purpose, otc - active ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive ingredients: borate, boric acid, sodium chloride, calcium chloride, l-carnitine, sodium hyaluronate
Indications & Usage
Uses
*For the temporary relief of burning and irritation due to dryness of the eye * For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun * For use as a protectant against further irritation or to temporarily relieve dryness of the eye
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
Otc - Purpose
I am not sure what is meant by purpose. There are the uses which is this section:
Uses
*For the temporary relief of burning and irritation due to dryness of the eye * For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun * For use as a protectant against further irritation or to temporarily relieve dryness of the eye
Then in the active ingredients section it describes the purpose like this:
Active ingredient Purpose
Glycerin 0.25%................................... Eye Lubricant
Otc - Active Ingredient
Active ingredient Purpose
Glycerin 0.25%................................... Eye Lubricant
Package Label.Principal Display Panel
HydroPure box and label Page 1.jpg
HydroPure box and label Page 2.jpg
* Please review the disclaimer below.
