Hyclodex by Marnel Pharmaceuticals, Inc. HYCLODEX-

Hyclodex by

Drug Labeling and Warnings

Hyclodex by is a Other medication manufactured, distributed, or labeled by Marnel Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HYCLODEX 
dressing, wound, drug

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:00682-0048

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:00682-0048-1	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K113693	02/26/2018

Labeler - Marnel Pharmaceuticals, Inc. (080161449)