HYCLODEX- dressing, wound, drug    
Marnel Pharmaceuticals, Inc.

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Hyclodex

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.

DOES NOT CONTAIN ANTIBIOTICS, STEROIDS, PEROXIDE OR ALCOHOL.

For Topical Use Only - Rx Only

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

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:  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.

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

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:  HyclodexTM is available in 59 ml spray solution.

image description

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)

Revised: 3/2018
Document Id: dc265627-64c8-476f-aff1-0029f8c6caef
Set id: c12ab208-426e-4423-af18-b50f6bb38bbf
Version: 2
Effective Time: 20180301
 
Marnel Pharmaceuticals, Inc.