Label: SALINAAX EYE WASH- water rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 24, 2018

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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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