GREENGLO (LISSAMINE GREEN) STRIP [HUB PHARMACEUTICALS, INC.]

GREENGLO (LISSAMINE GREEN) STRIP [HUB PHARMACEUTICALS, INC.]
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NDC 17238-920-11, 17238-920-98
Set ID 16a8622b-b349-4b10-b45a-f1f1551b2b06
Category HUMAN PRESCRIPTION DRUG LABEL
Packager HUB Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number
  • Product Facts

    Each sterile strip is impregnated with 1.5 mg. of Lissamine Green

  • INDICATIONS:

    For use as a diagnostic agent when superficial corneal or conjunctival tissue change is suspected.

  • DIRECTIONS FOR USE:

    For best viewing and patient comfort, the Lissamine Green impregnated tip should be moistened with one or two drops of sterile irrigating or saline solution before application. Apply moistened tip to conjunctiva or fornix as required. It is recommended that the patient blink several times after application.

    HUB_GreenGlo Instructions For Opening Strips

    1. Hold package in middle and tear down toward sterile strip

    2. Turn over and tear down from other side, taking care not to tear the sterile strip.

    3. Grasp each end of package firmly as shown, without touching the sterile strip, and pull apart.

  • NOTE:

    Not to be used with soft contact lenses. For external use only. Keep out of the reach of childred.

  • HOW SUPPLIED:

    Dispenser carton containing 100 strips.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Contacare Ophthalmics & Diagnositics (EOU)

    Block No. 310, Village Sim of Dabhasa, Taluka: Padra,

    Dist.: Vadodara - 391 440, Gujarat, India.

    Mfg. Lic. No. G/1197

    Manufactured for, and distributed by:

    HUB Pharmaceuticals, LLC

    Rancho Cucamonga, CA 91730

    www.hubrx.com

    European Representative:

    MDT J.Zych, A. Budyn Sp j.

    ul. Skosna 12A, 30-383 Krakow, Poland

  • Representative Packaging:

    HUB_GreenGlo Strip

    17238-920-98: GreenGlo individual Strip (above)

    HUB_GreenGlo Box

    17238-920-11: Dispenser Carton containing 100 strips (above)

  • INGREDIENTS AND APPEARANCE
    GREENGLO 
    lissamine green strip
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17238-920
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIGHT GREEN SF YELLOWISH (UNII: 3F7BHA64Z0) (LIGHT GREEN SF YELLOWISH - UNII:3F7BHA64Z0) LIGHT GREEN SF YELLOWISH1.5 mg  in 1.5 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17238-920-11100 in 1 BOX04/01/2012
    1NDC:17238-920-981.5 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2012
    Labeler - HUB Pharmaceuticals, Inc. (611747945)
    Establishment
    NameAddressID/FEIBusiness Operations
    OMNI LENS PRIVATE LIMITED862170057manufacture(17238-920)