FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC- water solution

First Aid Direct Buffered Eyewash Sterile Isotonic by

Drug Labeling and Warnings

First Aid Direct Buffered Eyewash Sterile Isotonic by is a Otc medication manufactured, distributed, or labeled by Cintas, Horizon Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Purified water, 98.525%

Purpose

eyewash

Uses

for irrigating the eye to help relieve irritation, discomfort, burning, stinging, smarting, or itching by removing loose foreign material, air pollutants (smog or pollen), or chlorinated water.

Warnings

• to avoid contamination, do not touch tip of container to any surface, Do not reuse. Once opened, discard.
• obtain immediate medical treatment for all open wounds in or near the eyes

Do not use

• if solution changes color or becomes cloudy
• with contact lenses
• for injection

Stop use and ask a doctor if

• you experience eye pain, changes in vision, continued redness, or irritation
• condition worsens or persists

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Twist top to remove.
• Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Inactive ingredients

benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

PRINCIPAL DISPLAY PANEL - 1 fl oz Bottle Label

Buffered
Eyewash

STERILE ISOTONIC
SOLUTION 1 fl oz

INGREDIENTS AND APPEARANCE

FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC 
water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-300
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R)	Water	0.98 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium chloride (UNII: F5UM2KM3W7)
Edetate disodium (UNII: 7FLD91C86K)
Sodium chloride (UNII: 451W47IQ8X)
Sodium phosphate, Dibasic, Heptahydrate (UNII: 70WT22SF4B)
Sodium phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-300-20	4 in 1 BOX, UNIT-DOSE	10/01/2011
1		30 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	10/01/2011

Labeler - Cintas (056481716)

Registrant - Horizon Pharmaceuticals, Inc. (960418825)

Establishment
Name	Address	ID/FEI	Business Operations
Horizon Pharmaceuticals, Inc.		960418825	MANUFACTURE(42961-300) , STERILIZE(42961-300) , LABEL(42961-300) , PACK(42961-300) , ANALYSIS(42961-300)