Eye Irrigating
FDA Label NDC 50090-0382

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Eye Irrigating (NDC 50090-0382). 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 active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Purified water 99.05%

Purpose

Eyewash

Uses

washes the eye to help relieve:

  • irritation
  • stinging
  • itching
    by removing:
  • loose foreign material
  • air pollutants (smog or pollen)
  • chlorinated water

Warnings

Do not use if solution changes color or becomes cloudy

When using this product  

  • remove contact lenses before use
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use

    • 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
    • you have open wounds in or near the eye

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • flush the affected eye(s) as needed
  • control the rate of flow of solution by placing pressure on the bottle

    • When using an eye cup

    • rinse the cup with clean water immediately before each use
    • avoid contamination of the rim and inside surfaces of the cup
    • fill the cup half full and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquid
    • tilt the head backward. Open eyelid wide and rotate eyeball to ensure thorough bathing with the wash
    • rinse the cup with clean water after each use

Other Information

  • store at 15° - 30°C (59° - 86°F)
  • keep tightly closed

Inactive Ingredients

boric acid, sodium borate and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: edetate disodium 0.025% and sorbic acid 0.1%.

Questions Or Comments?

1-800-645-2158

Serious side effects associated with use of this product may be reported to this number.

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

© Rugby Laboratories
REV. 04/13 R-115

Re-order No. 370044

6998603

AK07025

How Supplied

Product: 50090-0382

NDC: 50090-0382-0 118 mL in a BOTTLE

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