SALINAAX EYE WASH (WATER) RINSE [AAXIS PHARMACEUTICALS INC DBA AAXIS PACIFIC]

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SALINAAX EYE WASH (WATER) RINSE [AAXIS PHARMACEUTICALS INC DBA AAXIS PACIFIC]
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NDC 68276-006-01, 68276-006-02, 68276-006-03, 68276-006-04, 68276-006-05
Set ID af98b38e-4f2c-431a-a57b-fc03387da51d
Category HUMAN OTC DRUG LABEL
Packager Aaxis Pharmaceuticals Inc Dba Aaxis Pacific
Generic Name
Product Class
Product Number
Application Number PART349
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  • Active Ingredient

    Purified water USP 98.6%

  • Purpose

    Eye Wash

  • Uses:

    For irrigating the eye to help relieve irritation by removing loose foreign material, air pollutants, and chlorinated water.

  • Warnings

    Do not use

    • If solution changes color or becomes cloudy
    • If snap off top is broken or missing

    When using this product

    • Remove contact lenses before use
    • Do not touch the tip of container to any surface to acoid contamination

    Stop use and consult a doctor

    • If you experience eye pain, change in vision, continued redness or irritation of the eye
    • If condition worsens or persists
    • If there are open wounds in or near the eye

    Keep out of reach of children

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

  • Directions

    • Twist snap-off top to open
    • Flush affected eye as needed, controlling the rate of flow of solution by pressure on the container
    • DO not reuse
    • Discard container after use
  • Storage

    Store out of direct sunlight between 590F and 860F (150C and 300C)

  • Inactive Ingredients:

    PHMB,Potassium phosphate monobasic, sodium chloride USP, sodium hydroxide.

  • Questions

    Tel: 1-424-263-5294

  • Principal Display Panel

    NDC numbers - 68276-006-01, 02, 03, 04, 05

    Salinaax

    EYE WASH

    Sterile Buffered Isotonic Solution with Preservative

    For emergency eye cleaning and First Aid use.

    Cleans, refreshes, soothes

    TAMPER-EVIDENT CAP
    DO NOT USE IF SNAP-OFF TOP IS BROKEN OR MISSING


    STERILEA

    Sterile using aseptic processing technique

    68786-006-05.......... 0.5 fl.oz (15mL)

    68786-006-01.......... 5.0 fl.oz (148mL)

    68786-006-02.......... 8.0 fl.oz (236mL)

    68786-006-03.......... 16 fl.oz (472mL)

    68786-006-04.......... 32 fl.oz (944mL)

    Label

  • INGREDIENTS AND APPEARANCE
    SALINAAX  EYE WASH
    water rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68276-006
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water98.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Potassium phosphate, monobasic (UNII: 4J9FJ0HL51)  
    Sodium chloride (UNII: 451W47IQ8X)  
    Sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68276-006-01148 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2010
    2NDC:68276-006-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2010
    3NDC:68276-006-03472 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2010
    4NDC:68276-006-04944 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2010
    5NDC:68276-006-0515 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/18/2010
    Labeler - Aaxis Pharmaceuticals Inc Dba Aaxis Pacific (049082677)
    Registrant - Opto-Pharm Pte Ltd (595239682)
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