HypoCyn: Package Insert and Label Information

HYPOCYN-
Marnel Pharmaceuticals, Inc.

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: one 2-ounce bottle with spray applicator.

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: 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: 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.

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HYPOCYN
Product Information
Product Type Item Code (Source) NHRIC:0682-0046
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:0682-0046-01 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 09/12/2018
Labeler — Marnel Pharmaceuticals, Inc. (080161449)

Revised: 09/2018 Marnel Pharmaceuticals, Inc.

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