FDA Label for Pure Eyes Sterile Eyes

View Indications, Usage & Precautions

Pure Eyes Sterile Eyes Product Label

The following document was submitted to the FDA by the labeler of this product Samson Pharmaceutical. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



DRUG FACT

Manufactured by:
Samson Pharmaceutical
Commerce, CA 90040
Made in USA


Otc - Purpose



ACTIVE INGREDIENTSPURPOSE
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

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