Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

EYE IRRIGATING- purified water solution 
Rugby Laboratories Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

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

Package/Label Principal Display Panel

Rugby®

NDC: 0536-0901-97

GENTLE CLEANSING

SOLUTION

FOR EVERYDAY USE

Eye

Irrigating

Solution

Eases Irritation

Soothes Burning

& Stinging

Relieves Itching

THIMEROSAL FREE

Isotonic

Buffered Solution

STERILE

4 fl oz

(118 mL)

EYE IRRIGATING 
purified water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-0901
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	99.05 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-0901-97	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/07/2011	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		10/07/2011	01/31/2019

Labeler - Rugby Laboratories Inc. (079246066)

Revised: 9/2019

Document Id: 420fdca4-e125-453c-845d-838b57c7bd24

34390-5

Set id: 230a9605-f7a6-4429-a358-04f112101379

Version: 3

Effective Time: 20190905