Otc - Active Ingredient
Active ingredients
Glycerin 0.25%
Naphazoline HCI 0.012%
Redness And Dry Eye Relief Solution
FDA Label NDC 55651-620
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kc Pharmaceuticals, Inc for the product Redness And Dry Eye Relief (NDC 55651-620). 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, otc - keep out of reach of children, inactive ingredients, dosage & administration, indications & usage, warnings, 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
Otc - Purpose
Active ingredients Purposes
Glycerin 0.25%........................................................Lubricant
Naphazoline HCI 0.012%........................................Redness reliever
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.
Inactive Ingredients
benzalkonium chloride, boric acid, edetate disodium,
purified water, sodium borate
Dosage & Administration
Directions:
instill 1 to 2 drops Ianthe affected eye(s) up to 4 times daily
Indications & Usage
Uses
■ relieves redness of the eye due to minor eye irritations
■ for use as a protectant against further irritation or to relieve dryness of the eye
■ for the temporary relief of burning and irritation due to dryness of the eye
Warnings
Warnings
For external use only
Do not use if solution changes color or becomes cloudy
Ask a doctor before use if you have narrow angle glaucoma
When using this product
■ to avoid contamination, do not touch tip of container to any surface
■ replace cap after using
■ overuse may produce increased redness of the eye
■ pupils may become enlarged temporarily
Stop use and ask a doctor if
■ you experience eye pain
■ you experience changes in vision
■ you experience continued redness or irritation of the eye
■ the condition worsens or persists for more than 72 hours
* Please review the disclaimer below.
