HypoCyn by Summers Laboratories, Inc. HYPOCYN-

HypoCyn by

Drug Labeling and Warnings

HypoCyn by is a Other medication manufactured, distributed, or labeled by Summers Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

INDICATIONS FOR USE:

HypoCyn™ Antimicrobial Dermal Spray Solution is intended 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 HypoCynTM Antimicrobial Dermal Spray 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.

INSTRUCTIONS FOR USE

DIRECTIONS FOR USE:

Spray HypoCyn™ Antimicrobial Dermal Spray Solution to the affected area 2 times daily, or as directed by a healthcare professional. 

DESCRIPTION

DESCRIPTION:

HypoCyn™ Antimicrobial Dermal Spray Solution is a proprietary skin solution containing balanced analytic hypochlorous acid as a preservitive, which is know to be safe and fast acting in the removal of microorganisms of the skin. 

CONTRAINDICATIONS

CONTRAINDICATIONS:

Check for known hypersensitivity to any of the HypoCyn™ Antimicrobial Dermal Spray Solution ingredients. 

STORAGE AND HANDLING

STORAGE:

Keep away from direct sunlight and heat sources.  Do Not Freeze.

HANDLING AND DISPOSAL:

HypoCyn™ Antimicrobial Dermal Spray Solution is non-irritating, non-cytotoxic and non-sensitizing to skin.  Special handling or disposal precautions are not required. 

SPL UNCLASSIFIED SECTION

SAFETY:

HypoCyn™ Antimicrobial Dermal Spray Solution is non-irritating and non-sensitizing, 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.

HOW SUPPLIED

HOW SUPPLIED:

HypoCyn™ Antimicrobial Dermal Spray Solution is supplied in an 8 fl. oz. (237ml) bottle. 

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN.

SPL UNCLASSIFIED SECTION

DOES NOT CONTAIN ANTIBIOTICS, STEROIDS, PEROXIDE OR ALCOHOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYPOCYN 
dressing, wound, drug

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:11086-058

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:11086-058-01	237 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	03/14/2022

Labeler - Summers Laboratories, Inc. (232386772)