Drug Facts
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Redness Relief Solution/ Drops
FDA Label NDC 55758-511
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Redness Relief (NDC 55758-511). 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 drug facts, active ingredients and purposes, active ingredients purposes, use, warnings, do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients And Purposes
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Active Ingredients Purposes
Glycerin 0.25%..........................Lubricant
Naphazoline 0.012%.................. Redness reliever
Use
- relieves redness of the eye due to minor eye irritations
- temporarily relieves dryness of the eye due to burning and irritation
- protects against further irritation
Warnings
FOR EXTERNAL USE ONLY.
Do Not Use
if solution changes color or becomes cloudy, do not use
Ask A Doctor Before Use If You Have
narrow angle glaucoma
When Using This Product
- pupils may become enlarged temporarily
- to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
- if solution changes color or becomes cloudy, do not use
- overuse may produce increased redness of the eye
- remove contact lenses before using
Stop Use And Ask A Doctor If
- you experience
- eye pain
- changes in vision
- continued redness or irritation of the eye
- condition worsens or persists for more than 72 hours
If Pregnant Or Breast-Feeding,
consult a doctor before using this product.
Keep Out Of Reach Of Children.
If swallowed get medical help or contact a Poison Control Center immediately.
Directions
- put 1 to 2 drops in the affected eye(s) up to 4 times daily
Other Information
- store between 59-86˚F (15-30˚C)
Inactive Ingredients
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate
Questions Or Comments?
+1-866-359-3478 (M-F) 9AM – 5PM EST or www.pharmadel.com
Dist. By/ Por: Pharmadel Llc
New Castle, DE 19720
www.pharmadel.com
+1-866-359-3478
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