Xpect Buffered Eyewash Sterile Isotonic (Water) Solution [Cintas] -

XPECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]
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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

XPECT BUFFERED EYEWASH STERILE ISOTONIC
water solution

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:42961-301-20	4 in 1 BOX, UNIT-DOSE	10/01/2011
1		30 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product

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

Labeler - Cintas Corporation (056481716)

Registrant - Cintas Corporation (056481716)

Name	Address	ID/FEI	Business Operations
Establishment
Horizon Pharmaceuticals, Inc.		960418825	MANUFACTURE(42961-301) , STERILIZE(42961-301) , LABEL(42961-301) , PACK(42961-301) , ANALYSIS(42961-301)

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