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DRUG FACT
Manufactured by:
Samson Pharmaceutical
Commerce, CA 90040
Made in USA
Pure Eyes Sterile Eyes Solution/ Drops
FDA Label NDC 20146-7000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Samson Pharmaceutical for the product Pure Eyes Sterile Eyes (NDC 20146-7000). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| ACTIVE INGREDIENTS | PURPOSE |
|---|---|
| Naphazoline HCL 0.01% | Redness reliever |
| Glycerin 0.25% | Lubricant |
Uses
♦ Relieve redness of the eye due to minor irritation♦ Temporary relief of burning and irritation due to dryness of the eye♦ Protects against further irritation
Warnings
For external use only
Otc - Do Not Use
Do not use if solution changes color or becomes cloudy
Otc - Ask Doctor
Ask a doctor before use if you have
♦ Narrow angle glaucoma
Otc - When Using
When using this product
♦ Do not touch tip of container to any surface to avoid contamination♦ Do not overuse as it may products increased redness of the eye♦ Pupils may be come enlarged temporarily♦ Remove contact lenses before using♦ Replace cap after use
Otc - Stop Use
Stop use and ask a doctor if
♦ You experience eye pain, changes in vision, continued redness or irritation of the eyes♦ Conditions worsens or persists for more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep put of reach of children. Id swallowed, get medical help or contact a Poison Control Center right away.
Directions
♦ Instill 1 to 2 drops in the affected eye(s) up to 4 times daily
Other Information
♦ Store at 15- 30 C (59-86 F)♦ Keep tightly closed♦ Use before expiration date marked on the carton and bottle♦ Serious side effect associated with use of the product may be reported to the phone number provided below
Inactive Ingredients
benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate.
Question?
1-888-995-9935
Principal Display Panel - 7 Ml Bottle Blister Pack
POCKET SIZE
MAXIMUM
REDNESS RELIEF
Pure
Eyes®
STERILE
EYE DROPS
✓ Relieves✓ Protects✓ Soothes✓ Moisturizes
Made in the U.S.A.
0.24 FL OZ (7ML)
Principal Display Panel (7 mL Bottle Blister Pack)
* Please review the disclaimer below.
