Label: STERILE ISOTONIC BUFFERED GENUINE EYEWASH- water liquid

  • 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 July 12, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Purified Water USP...q.s.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Sodium Chloride USP                                          44mg

    Monobasic Sodium Phosphate USP                18mg

    Sodium Phosphate Dibasic USP                       111mg 

    Edetate Disodium USP                                       10mg

    Benzalkonium Chloride                                      0.5mg
    NF (as preservative)


  • STORAGE AND HANDLING

    Store in a cool place. For irrigation only.

    Discard unused portion of the solution.

    Not for injection.


  • WARNINGS

    Warning:

    If you experience eye pain, changes in vision, continued redness or irritation of the eye,

    or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

    Do not use if solution changes color or becomes cloudy.

  • DOSAGE & ADMINISTRATION


    Directions

    Remove contacts before using.

    Twist top to remove.

    Flush the affected area as needed. Control

    Rate of flow by pressure on the bottle. Do not touch

    tip of the container to any surface. Do not reuse.

    If necessary continue flushing with emergency eyewash or shower.

    Discard bottle after use.

  • PURPOSE


    Uses:

    For flushing or irrigating the eyes to

    remove loose foreign material, air pollutants,

    or chlorinated water.
  • DESCRIPTION

    Code No.: GUJ/DRUG/G/1080

    Batch No.:

    Mfg Date:

    Exp: Date:


  • PRINCIPAL DISPLAY PANEL

    10ml

    Sterile Isotonic Buffered Genuine

    Eyewash

    For single use only

  • PRINCIPAL DISPLAY PANEL

    eyewash10ml
  • INGREDIENTS AND APPEARANCE
    STERILE ISOTONIC BUFFERED GENUINE EYEWASH 
    water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0005
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.16 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0005-110 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/16/2010
    Labeler - Genuine First Aid (619609857)
    Establishment
    NameAddressID/FEIBusiness Operations
    Stericon Pharma Pvt. Ltd.916147736manufacture
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