DRY EYE TEST (FLUORESCEIN SODIUM) STRIP [NOMAX INC.]

DRY EYE TEST (FLUORESCEIN SODIUM) STRIP [NOMAX INC.]
PDF | XML

NDC 51801-008-15
Set ID 04866053-f973-471e-b3bc-241fb76303a2
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Nomax Inc.
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    Dry Eye Test Fluorescein Sodium Ophthalmic Strips U.S.P. diagnostic agent is for professional use only

    Each strip is impregnated with 0.12 mg of fluorescein sodium USP.

  • INDICATIONS

    For testing tear film stability by determining the fluorescein break-up time (FBUT).

  • CONTRAINDICATIONS

    Hypersensitivity to components or mercury-containing compounds.

  • DIRECTIONS FOR USE

    Procedure for measuring Fluorescein

    Break-up Time (FBUT) with Amcon Dry Eye Test Strips.

    1. Apply one or two drops of non-preserved saline to the

    impregnated paper tip. Excess fluid will automatically fall off.

    Shaking is neither

    required nor desirable.

    2. Ask the patient to look down and in.

    3. Gently touch the strip to the superior temporal bulbar conjunctiva

    for one or two seconds.

    4. Ask the patient to blink three times and open eyes naturally.

    5. Conduct the FBUT measurements immediately.

    6. Perform two consecutive measurements. If not consistent, conduct

    a third and average the results.

    7. Repeat steps 1 through 6 using a new strip for the second eye

    FBUT values of less than 10 seconds are considered abnormal. Values less than 5 seconds are indicative of dry eye disorder. Values of 5 to 9 seconds are borderline dry eye.

    NOTE: The contents may not be sterile if the individual strip package has been damaged or previously opened. This product is intended for external use only. Keep out of reach of children. Store below 30°C.

  • HOW SUPPLIED

    Carton of 50 pouches of two strips each.

  • Grasp free tab ends of overwrap and slowly pull apart. Peel the overwrap back until the entire strip is exposed. 2. Gently lift the exposed strip off of the overwrap without damaging the impregnated tip.

  • SPL UNCLASSIFIED SECTION

    Nomax, Inc. • St. Louis, MO 63123 USA

    Rev. 12/13
    MSN 015-153

  • PRINCIPAL DISPLAY PANEL - 100 Sterile Strips (50 Pouches of 2 Strips Each)

    DET box

  • INGREDIENTS AND APPEARANCE
    DRY EYE TEST 
    fluorescein sodium strip
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51801-008
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fluorescein Sodium (UNII: 93X55PE38X) (FLUORESCEIN - UNII:TPY09G7XIR) FLUORESCEIN0.12 mg
    Product Characteristics
    ColorORANGE (paper is white and tip is orange) Score    
    ShapeRECTANGLE (with tapered end) Size52mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51801-008-1550 in 1 CARTON12/05/2013
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER12/05/2013
    Labeler - Nomax Inc. (103220273)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nomax Inc.103220273MANUFACTURE(51801-008)

Related Drugs