Label: HYCLODEX-

  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated March 1, 2018

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

  • INDICATIONS & USAGE

    INDICATIONS FOR USE:

    HyclodexTM Rx is intented to be used under the supervison of a health care professional for cleaning and removal of microorganisms, debris, and foreign material affecting various dermatologic skin conditions.  Apply HyclodexTM solution liberally on site to clean.  Do not remove or wipe off.  If use of dressing is required, apply liberally to dressing.  No rinsing is required.

  • INFORMATION FOR OWNERS/CAREGIVERS

    DOES NOT CONTAIN ANTIBIOTICS, STEROIDS, PEROXIDE OR ALCOHOL.

  • INFORMATION FOR OWNERS/CAREGIVERS

    For Topical Use Only - Rx Only

  • SUMMARY OF SAFETY AND EFFECTIVENESS

    PRODUCT SUMMARY:  HyclodexTM is a proprietary skin solution containing balanced analytic hypochlorious acid as a preservative, which is known to be safe and fast acting in the removal of microorganisms of the skin.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS:  Check for known hypersensitivity to any of the HyclodexTM solution ingredients.

  • INSTRUCTIONS FOR USE

    DIRECTIONS OF USE:  Spray HyclodexTM on a clean gauze pad.  Thoroughly apply to affected areas and allow product to fully dry on skin.  Apply product 2 times per day or as directed.

  • STORAGE AND HANDLING

    STORAGE:  Store at a controlled room temperature of 65ο to 75ο F.  Keep away from direct sunlight and heat sources.  Do Not Freeze.

    Handling and Disposal:  HyclodexTM is non-irritating, non-cytoxic and nonsensitizing to skin and eyes.  Special handling or disposal precautions are not required.

  • SAFE HANDLING WARNING

    SAFETY:  HyclodexTM is non-irritating and nonsensitizing having passed bio-compatibility studies including, ISO ocular irritation and ISO Maximum Sensitivity test.

  • 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.  Keep out of reach of children.

  • HOW SUPPLIED

    HOW SUPPLIED:  HyclodexTM is available in 59 ml spray solution.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HYCLODEX 
    dressing, wound, drug
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:00682-0048
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:00682-0048-159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK11369302/26/2018
    Labeler - Marnel Pharmaceuticals, Inc. (080161449)