EYE DROPS (GLYCERIN) SOLUTION [OPTO-PHARM PTE LTD]

EYE DROPS (GLYCERIN) SOLUTION [OPTO-PHARM PTE LTD]
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NDC 46823-001-05
Set ID 078b9b91-9161-415e-9994-58940b9dfe1e
Category HUMAN OTC DRUG LABEL
Packager Opto-Pharm Pte Ltd
Generic Name
Product Class
Product Number
Application Number PART346
  • Active Ingredient

    Glycerin.....1.0%

  • Purpose


    Lubricant


  • Uses

    • For use as a lubricant to prevent further irritation or to relieve dryness of the eye
    • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • Warnings

    For external use only

    Do not use 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 using

    Stop use and ask a doctor if

    • you experience eye pain
    • you experience changes in vision
    • you experience continued redness or irritation of the eye
    • the condition worsens or persists for more than 72 hours

    Keep out of reach of children

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

  • Directions

    Instill 1 or 2 drops in the affected eye(s) as needed

  • Other informations

    • store in the refrigerator
    • do not freeze
    • store in dark, cool place away from sunlight
    • once open, discard container and any contents after 30 days
    • use before expiration date marked on container
    • prior to drop instillation, contact lenses should be removed and reinserted after 10 minutes
  • Inactive ingredients

    boric acid, citric acid, hypromellose, N-acetyl-carnosine, potassium bicarbonate, purified benzyl alcohol, sterile water

  • Questions

    +65-68614801

  • Principal Display Panel

    NDC 46823-001-05

    STERILE LUBRICANT EYE DROPS


    2X0.17 fl oz/5 ml vials

    (Net 0.34 fl oz/10 ml)

    Label


  • INGREDIENTS AND APPEARANCE
    EYE DROPS 
    glycerin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46823-001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    N-ACETYLCARNOSINE (UNII: 0TPN86OQIF)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46823-001-0510 g in 1 VIAL; Type 0: Not a Combination Product03/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/06/2017
    Labeler - Opto-Pharm Pte Ltd (595239682)
    Registrant - Opto-Pharm Pte Ltd (595239682)

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