Label: BIOGLO- fluorescein sodium strip

  • NDC Code(s): 17238-900-11, 17238-900-30, 17238-900-99
  • Packager: HUB Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 18, 2019

If you are a consumer or patient please visit this version.

  • Product Facts

    Each sterile strip is impregnated with 1 mg. of fluorescein sodium U.S.P.

  • INDICATIONS:

    For staining the anterior segment of the eye when fitting contact lenses, in disclosing corneal injury and in applanation tonometry.

  • DIRECTIONS FOR USE:

    To insure full fluorescence and patient comfort, the BioGlo impregnated tip should be moistened before application. One or two drops of sterile irrigating or saline solution should be used for this purpose. Touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application.

    HUB_BioGlo Instructions For Opening Strips

    1. Grasp tabs between thumbs & index fingers
    2. Gently pull tabs apart
    3. Remove strip taking care to touch only the white portion of the strip
  • STORAGE:

    Keep at room temperature.

  • NOTE:

    For external use only. Contents may not be sterile if individual strips have been damaged or previously opened.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • HOW SUPPLIED:

    Dispenser carton containing 100 or 300 strips.

  • SPL UNCLASSIFIED SECTION

    HUB Pharmaceuticals, LLC

    Rancho Cucamonga, CA 91730

    www.hubrx.com

    Mfr. Lic. No. G/1197

    European Representative:

    Biovision Limited

    Wayside, Tring Road, Wellhead, Dunstable, BEDS LU6 2JU, UK

  • Representative Packaging:

    HUB BioGlo Pouch

    17238-900-99: BioGlo Individual Pouch (above)

    HUB BioGlo 100 Carton

    17238-900-11: Dispenser Carton containing 100 strips (above)

    HUB BioGlo 300 Carton

    17238-900-30: Dispenser Carton containing 300 strips (above)

  • INGREDIENTS AND APPEARANCE
    BIOGLO 
    fluorescein sodium strip
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17238-900
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUORESCEIN SODIUM (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN SODIUM1 mg  in 1 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17238-900-11100 in 1 BOX04/01/2018
    1NDC:17238-900-991 mg in 1 PACKET; Type 0: Not a Combination Product
    2NDC:17238-900-30300 in 1 BOX04/01/2018
    2NDC:17238-900-991 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(17238-900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Madhu Instruments Pvt.Ltd.915827852manufacture(17238-900)