EYE STREAM (PURIFIED WATER) SOLUTION [ALCON LABORATORIES, INC.]

EYE STREAM (PURIFIED WATER) SOLUTION [ALCON LABORATORIES, INC.]
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NDC 0065-0530-01, 0065-0530-04
Set ID ff9560df-d834-57a8-37b0-3f10e82f5a5d
Category HUMAN OTC DRUG LABEL
Packager Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Drug Facts

    NDC 0065-0530-01

    Active IngredientPurpose
    Purified Water 98.6%                  Eye Irrigation
  • Inactive Ingredients

    Benzalkonium Chloride 0.013% as preservative, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Potassium Chloride, Sodium Acetate Trihydrate, Sodium Chloride, Sodium Citrate Dihydrate, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.  The pH range of solution is in the physiologic range.

  • Uses

    For irrigating the eye to help relieve irritation, discomfort and burning by removing loose foreign material, air pollutants (smog or pollen), or chlorinated water.

  • Warnings

    For external use only
    Obtain immediate medical treatment for all open wounds in or near the eyes. 
    This product is not to be used as a saline solution for rinsing and soaking soft contact lenses.

    NOT FOR INJECTION OR INTRAOCULAR SURGERY.

  • Do not use

    • if solution changes color or becomes cloudy.
    • if you are sensitive to any ingredient in this product.
  • When using this product

    • remove contact lenses before using.
    • to avoid contamination, do not touch tip of container to any surface.
    • replace cap after using.
  •  Stop use and ask a doctor if you experience

    • eye pain
    • changes in vision
    • continued redness
    • irritation of the eye
    • if the condition worsens or persists for more than 72 hours
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 
    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

  • Other Information

    Store at 8o – 27oC (46o – 80oF)

  • Questions?

    In the U.S.,
    Call 1-800-757-9195

    Drug Facts

    NDC 0065-0530-04

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Purified Water 98.6%                  Eye Irrigation
  • Uses

    For irrigating the eye to help relieve irritation, discomfort and burning by removing loose foreign material, air pollutants, (smog or pollen), or chlorinated water.

  • Warnings

    For external use only

    Obtain immediate medical treatment for all open wounds in or near the eyes.

    This product is not to be used as a saline solution for rinsing and soaking soft contact lenses.

    NOT FOR INJECTION OR INTRAOCULAR SURGERY.

  • Do not use

    • if this solution changes color or becomes cloudy.
    • if you are sensitive to any ingredient in this product.
  • When using this product

    • remove contact lenses before using.
    • to avoid contamination, do not touch tip of container to any surface.
    • replace cap after using
  • Stop use and ask a doctor if you experience

    • eye pain
    • changes in vision
    • continued redness
    • irritation of the eye
    • if the condition worsens or persists for more than 72 hours
  • Keep out of reach of children

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

  • Directions

    Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

  • Other Information

    Store at 8°-27°C (46°-80° F)

  • Inactive Ingredients

    Benzalkonium Chloride 0.013% as a preservative, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Potassium Chloride, Sodium Acetate Trihydrate, Sodium Citrate Dihydrate, Sodium Chloride and Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.  The pH of the solution is in the physiological range.

  • Questions?

    In the U.S., Call 1-800-757-9195
    MedInfo@AlconLabs.com

  • PRINCIPAL DISPLAY PANEL

    NDC  0065-0530-01  

    eye stream
    ®
    eye wash solution sterile  

    Alcon®

    1 FL OZ (30 mL)

    Eye Stream Carton Image 1 oz
  • PRINCIPAL DISPLAY PANEL

    NDC 0065-0530-04

    eye stream®

    eye wash solution
    sterile

    Alcon®

    4 FL OZ (118 mL)

    Eye Stream Carton Image 4 oz
  • INGREDIENTS AND APPEARANCE
    EYE STREAM 
    purified water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0530
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water986 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Calcium Chloride (UNII: M4I0D6VV5M)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Sodium Acetate (UNII: 4550K0SC9B)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Trisodium Citrate Dihydrate (UNII: B22547B95K)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0530-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/1990
    2NDC:0065-0530-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/30/1990
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-0530)