HYPOCYN () [MARNEL PHARMACEUTICALS, INC.]

HYPOCYN () [MARNEL PHARMACEUTICALS, INC.]
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NDC 0682-0046-01
Set ID e832ba8c-57e9-462b-b9df-33ec2c919e57
Category PRESCRIPTION MEDICAL DEVICE LABEL
Packager Marnel Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number K113693
  • INDICATIONS & USAGE

    Rx Only

    Topical Use Only

    Spray Solution

    DAILY EYELID HEALTH MANAGEMENT

    INDICATIONS FOR USE:  HypoCyn™ is to be used by health care professionals for the cleaning and removal of microorganism, debris, and foreign material affecting the skin.

    Apply HypoCyn™ solution directly to the lid margin of the eyelid.  

  • HOW SUPPLIED

    HOW SUPPLIED:  one 2-ounce bottle with spray applicator.

  • INSTRUCTIONS FOR USE

    DIRECTIONS OF USE:

    Twice Daily - In the morning and in the evening

    1.  Wash hands prior to application.

    2.  Remove any makeup or lotions around your eyes.

    3.  Close your eye.

    4.  Apply 1 or 2 sprays directly to the eyelids.

    5.  Remove excess with a clean cloth if necessary.

    6.  Repeat on other eye.

    7.  Use twice daily

  • STORAGE AND HANDLING

    STORAGE:  Store at room temperature (65ο to 75ο F) away from direct sunlight and heat.  Do not freeze. HypoCyn™is non-flammable.

    HANDLING:  Non-cytotoxic, non-sensitizing and non-irritating to the skin and eyes.  Harmless to common surfaces.  No special handling precautions required.

  • WARNINGS AND PRECAUTIONS

    WARNINGS AND PRECAUTIONS:  For external use only.  Do not use for infusion or injection.  Do not swallow.  If you experience redness, swelling, irritation or pain, discontinue use and contact your doctor.  In case of sensitivities to chlorine, please exercise caution and consult with your doctor prior to use.  Do not use expired product.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HYPOCYN 
    dressing, wound, drug
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:0682-0046
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:0682-0046-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK11369309/12/2018
    Labeler - Marnel Pharmaceuticals, Inc. (080161449)

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