PURIFIED WATER- purified water solution/ drops

PURIFIED WATER by

Drug Labeling and Warnings

PURIFIED WATER by is a Otc medication manufactured, distributed, or labeled by OCuSOFT, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Purified Water

Purpose

Eye Wash

Uses

● in an emergency, to help flush loose foreign material or chemicals from the eye.
● to help relieve eye irriatation, burning, itching and stinging by removing air pollutants (smog or pollen) or chlorinated   water.

Warnings 

For external use only

Do not use

● if solution changes colors or becomes cloudy.

When using this product

● remove contact lenses before using.
● avoid contamination do not touch tip of container to any surface. 
● replace cap after using.
● overuse may cause more eye redness.

Stop use and ask a doctor if

● you experience eye pain.
● changes in vision occur.
● continued redness or irritation of the eye.
● condition worsens or persists for more than 72 hours.
● you experience any chemical burns.
● you experience any open wounds in or near the eyes. 

Keep this and all drugs out of the reach of children.

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

Directions

● flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Other information

● store at room temperature 15°-30°C (59°-86°F).

Inactive ingredients

Benzalkonium Chloride, Edetate Disodium, Potassium Chloride, Sodium Choride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic.

Questions or comments?

Call 800-233-5469   www. ocusoft.com

Principal Label Display

INGREDIENTS AND APPEARANCE

PURIFIED WATER  
purified water solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54799-565
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R)	Water	99.03 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Edetate Disodium (UNII: 7FLD91C86K)
Potassium Chloride (UNII: 660YQ98I10)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)
Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54799-565-59	118 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/01/2009
2	NDC: 54799-565-01	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	01/01/2009

Labeler - OCuSOFT, Inc. (174939207)