Eyesaline Concentrate

Dosage form: liquid
Ingredients: WATER 92.2mL in 100mL
Labeler: Sperian Eye & Face Protection Inc.
NDC Code: 64809-104

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.

Sperian Eyesaline Concentrate

Active Ingredient

Purified water 99.2%

Purpose

Emergency eyewash


Uses
  • for flushing or irrigating the eye to reduce the chancs of severe injury caused by acid, alkali, or particulate contamination

Warnings For external use only

Do not use
  • in concentrated form
  • while wearing contact lenses
  • if solution changes color or becomes cloudy
  • for injection
  • in intraocular surgery
  • internally
  • in open wounds in or near the eyes

When using this product
  • avoid contamination, do not touch tip of container to any surface
  • replace cap after use

Stop use and ask a doctor if you have
  • redness or irritation of eye after use
  • eye pain
  • changes in vision

Keep out of reach of children

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

Directions
  • to prepare solution dilute concentrate (1) part concentrate to (10) parts potable water before use
  • prepare sufficient quantity of constituted eyewash solution in advance of an emergency
  • mix concentrate with potable water to prepare eyewash solution as follows:
    • determine quantity of required eyewash solution
    • follow sanitary procedures
    • wear protective eyewear and gloves
    • pour 1/3 of required amount of potable water into mixing container or eyewash unit
    • add 1/3 of required amount of concentrate to water
    • agitate or mix thoroughly
    • repeat until required amount of solution is prepared
    • properly dispose of empty bottle after use
    • do not reuse
  • replace solution no longer than (6) months after mixing

Other information
  • do not use if seal is broken
  • do not freeze
  • store at room temperature, 15o to 30o C (59o to 86oF)

Inactive ingredients

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

Questions?

Call 1-800-430-5490

Sperian Eye and Face Protection Inc
(a Honeywell Company)
825 East Highway 151
Platteville, WI 53818 USA

Principal Display Panel

EYESALINE CONCENTRATE 
water liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64809-104
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (WATER) WATER92.2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
SODIUM PHOSPHATE, DIBASIC ANHYDROUS 
SODIUM CHLORIDE 
EDETATE DISODIUM 
BENZALKONIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:64809-104-182070 mL in 1 BOTTLE, PLASTIC
2NDC:64809-104-195323 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/08/2011
Labeler - Sperian Eye & Face Protection Inc. (013435034)
Establishment
NameAddressID/FEIOperations
Sperian Eye & Face Protection Inc013435034manufacture

Revised: 09/2011
 
Sperian Eye & Face Protection Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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