32-000509-0000-H5, 0498-0601: Eyesaline Concentrate

Eyesaline Concentrate by

Drug Labeling and Warnings

Eyesaline Concentrate by is a Otc medication manufactured, distributed, or labeled by Honeywell Safety Products USA, Inc, Sperian Eye & Face Protection, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EYESALINE CONCENTRATE- water liquid 
Honeywell Safety Products USA, Inc

----------

32-000509-0000-H5, 0498-0601: Eyesaline Concentrate

Active Ingredient

Purified water 92.14%

Purpose

Eyewash

Uses

  • For flushing or irrigating the eye to remove loose foreign material, air pollutants, or chlorinated water.

Warnings

For external use only-
Obtain immediate medical treatment for all open wounds in or near the eyes. To avoid contamination, do not touch tip of container to any surface. Replace cap after use.

Do not use

  • in concentrated form
  • while wearing contact lenses
  • if solution changes color or becomes cloudy
  • for injection
  • in intraocular surgery
  • internally
  • if eye is lacerated or object is embedded
  • if seal is broken

Stop use and consult a doctor if you have

  • changes in vision
  • continued reddness, irritation or pain, or if the condition worsens or persists

Keep out of reach of children

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

Directions

  • Concentrate must be diluted (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 eyewash solution required
  • 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 into 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 freeze

Inactive ingredients

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

Questions?

USA: 800-430-5490

Canada: 888-212-7233

Honeywell Safety Products USA, Inc. 855 S. Mint Street, Charlotte, NC, 28202

Package Label

IMAGE NAME IMAGE DELETE IMAGE REFERENCED 32-004623 Rev. H - NDC: <a href=/NDC/0498-0601-19>0498-0601-19</a>

EYESALINE CONCENTRATE 
water liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0498-0601
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER92.2 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-0601-182.07 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
2NDC: 0498-0601-195.32 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01809/01/202012/27/2024
Labeler - Honeywell Safety Products USA, Inc (118768815)

Revised: 12/2024
Document Id: 28eefeda-a7fb-7d20-e063-6394a90a3476
Set id: ad430082-6270-033c-e053-2995a90a1006
Version: 9
Effective Time: 20241210