Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 25c8f535-9bb0-4eee-8056-4dcdc4761918
Route
OPHTHALMIC
Published
Effective Date 2017-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Water (99.05 mL)
Inactive Ingredients
Boric Acid Sodium Borate Sodium Chloride Hydrochloric Acid Sodium Hydroxide Edetate Disodium Sorbic Acid

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2011-10-07

Description

Purified water 99.05%

Purpose

Eyewash

How Supplied

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


Medication Information

Purpose

Eyewash

How Supplied

Product: 50090-0382

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

Description

Purified water 99.05%

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
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
Purified Water
Active Ingredient

Purified water 99.05%

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

Keep Out of Reach of Children.

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


Structured Label Content

Uses

washes the eye to help relieve:

  • irritation
  • stinging
  • itching

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

Eyewash

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
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
How Supplied (HOW SUPPLIED)

Product: 50090-0382

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

Purified Water
Active Ingredient (Active ingredient)

Purified water 99.05%

Other Information (Other information)
  • store at 15° - 30°C (59° - 86°F)
  • keep tightly closed
Inactive Ingredients (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? (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

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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