EYE WASH SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]

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EYE WASH SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]
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NDC 50383-018-04
Set ID 3fa6e03d-9cc1-4817-8877-ae906f3a8b07
Category HUMAN OTC DRUG LABEL
Packager Hi-Tech Pharmacal Co., Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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  • Active ingredient

    Purified Water 98%

  • Purpose

    Eye Irrigation

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a PoisonControlCenter right away.

  • Uses

    •
    cleans the eyes to help relieve irritation, burning, stinging and itching
    •
    remove loose foreign material, air pollutants, or chlorinated water
  • Warnings

    Click here to enter Warnings

    Do Not Use

    •
    if you have an opened wound in or near the eyes; obtain medical treatment right away
    •
    if solution changes color or becomes cloudy

    When using this product

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

    Stop use and ask a doctor if

    •
    you experience eye pain or changes in vision
    •
    redness or irritation continues
    •
    condition worsens or persists
  • Directions

    •
    flush affected eye as needed
    •
    control the rate of flow of solution by placing pressure on the bottle
  • Inactive Ingredients

    boric acid, sodium borate, sodium chloride. Preserved with edetate disodium 0.025% & sorbic acid 0.1%.

  • Questions or comments?

    Call 1(800) 262-9010 Mon. - Thurs. 9 am - 4:30 pm EST, Fri. 9 am - 2:30 pm EST, Serious side effects associated with use of this product may be reported to this number.

  • Package/Label Principal Display Panel

    carton image

    THIMEROSAL FREE

    STERI OPTICS

    EYE WASH

    STERILE ISOTONIC BUFFERED SOLUTION

    Gentle Cleansing Solution for Everyday Use

    √ Ease Irritation

    √ Soothes Burning and Stinging

    √Relieves Itching

    4 FL. OZ. (118 mL)

  • INGREDIENTS AND APPEARANCE
    EYE WASH 
    eye wash solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50383-018
    Route of AdministrationINTRAOCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER980 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50383-018-041 in 1 CARTON01/07/1997
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/06/1997
    Labeler - Hi-Tech Pharmacal Co., Inc. (117696873)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Tech Pharmacal Co., Inc.117696873MANUFACTURE(50383-018)
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