Hyclodex: Package Insert and Label Information

HYCLODEX-
Marnel Pharmaceuticals, Inc.

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

SAFETY: Hyclodex TM 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: Hyclodex TM is available in 59 ml spray solution.

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HYCLODEX
Product Information
Product Type Item Code (Source) NHRIC:00682-0048
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:00682-0048-1 59 mL in 1 BOTTLE, SPRAY None
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)

Revised: 03/2018 Marnel Pharmaceuticals, Inc.

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