XPECT BUFFERED EYEWASH STERILE ISOTONIC- water solution
Cintas Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Xpect Buffered Eyewash Sterile Isotonic Solution

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

XPECT BUFFERED EYEWASH STERILE ISOTONIC
water solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42961-301
Route of Administration	OPHTHALMIC

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	08/31/2022

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)

Revised: 8/2022

Document Id: fb1bdc12-4796-4b6b-b9a0-5b557da168d6

Set id: 1418e8ad-8f33-4637-868e-ff8a124e10ce

Version: 4

Effective Time: 20220831

Cintas Corporation