Xpect Buffered Eyewash Sterile Isotonic Solution

Xpect Buffered Eyewash Sterile Isotonic Solution

Drug Labeling and Warnings

Drug Details

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XPECT BUFFERED EYEWASH STERILE ISOTONIC- water solution 
Cintas

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

Principal Display Panel - 1 fl oz Bottle Label
XPECT BUFFERED EYEWASH STERILE ISOTONIC 
water solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42961-301
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water0.98 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42961-301-204 in 1 BOX, UNIT-DOSE
130 mL in 1 BOTTLE, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34910/01/2011
Labeler - Cintas (056481716)
Registrant - Horizon Pharmaceuticals, Inc. (960418825)
Establishment
NameAddressID/FEIBusiness Operations
Horizon Pharmaceuticals, Inc.960418825MANUFACTURE(42961-301) , STERILIZE(42961-301) , LABEL(42961-301) , PACK(42961-301) , ANALYSIS(42961-301)

Revised: 2/2014
 
Cintas


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