FREDS DRY EYE RELIEF (GLYCERIN) SOLUTION [HANLIM PHARM. CO., LTD.]

FREDS DRY EYE RELIEF (GLYCERIN) SOLUTION [HANLIM PHARM. CO., LTD.]
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NDC 11716-1189-9
Set ID 96eb8fca-aaac-45c6-bc85-8acd40d8ce80
Category HUMAN OTC DRUG LABEL
Packager HANLIM PHARM. CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active ingredients                                                                Purpose

    Glycerin 0.2% ....................................................................Lubricant

    Polyethylene Glycol 400 1% ...............................................Lubricant

    Hypromellose 0.2% ............................................................Lubricant

  • PURPOSE

    Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for protection against further irritation
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • remove contact lenses before using
    • do not use if this solution changes color or becomes cloudy
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
  • STOP USE

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens or lasts more than 72 hours
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

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

  • INDICATIONS & USAGE

    Directions

    • put 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • some users may experience a brief tingling sensation
    • store at 15o to 25oC (59o to 77oF)
  • INACTIVE INGREDIENT

    Inactive ingredients: ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, glycine, magnesium chloride, potassium chloride, purified water,

    sodium borate, sodium chloride, sodium citrate, and sodium lactate

  • DOSAGE & ADMINISTRATION

    Distributed by: Fred's Inc.

                          4300 New Getwell Rd.

                          Memphis, TN 38118


    www.fredsinc.com

  • PRINCIPAL DISPLAY PANEL

    image of carton labelEnter section text here

  • INGREDIENTS AND APPEARANCE
    FREDS DRY EYE RELIEF 
    glycerin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-1189
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.002 mL  in 1 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.01 mL  in 1 mL
    HYPROMELLOSES (UNII: 3NXW29V3WO) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSES0.002 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    GLYCINE (UNII: TE7660XO1C)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11716-1189-91 in 1 CARTON
    115 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/06/2010
    Labeler - HANLIM PHARM. CO., LTD. (687986034)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANLIM PHARM. CO., LTD.687986034manufacture

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