HYPOCYN- dressing, wound, drug    
Summers Laboratories, Inc.

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HypoCyn™
Antimicrobial Dermal Spray Solution

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.

DIRECTIONS FOR USE:

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

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:

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

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. 

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:

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:

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

KEEP OUT OF THE REACH OF CHILDREN.

DOES NOT CONTAIN ANTIBIOTICS, STEROIDS, PEROXIDE OR ALCOHOL

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HYPOCYN 
dressing, wound, drug
Product Information
Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:11086-058
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:11086-058-01237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK11369303/14/2022
Labeler - Summers Laboratories, Inc. (232386772)

Revised: 3/2022
Document Id: 89a1020f-fff0-4adb-81c9-4f1bb7698570
Set id: dfa85798-79c5-424d-ab98-b293b9217294
Version: 1
Effective Time: 20220314
 
Summers Laboratories, Inc.