Puracyn^® Plus Professional Formula Frequently Asked Questions

Puracyn Plus Professional Formula is a family of non-toxic, pH-balanced, electrolyzed, hypochlorous acid-based solutions and a hydrogel. Puracyn Plus Professional Formula Wound Irrigation Solution is cleared by the Food and Drug Administration (FDA) for cleansing, debriding, and moistening acute and chronic wounds. Puracyn Plus Professional Formula Antimicrobial Hydrogel is cleared to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions including itch and pain relief. A complete description of cleared indications is provided below. The Puracyn Plus Professional Formula line of products has been scientifically tested as safe and non-irritating to the skin and wounds. The products maintain stability for up to 24 months.

FDA-Cleared Puracyn Plus Professional Formula Clinical Indications:

Puracyn Plus Professional Formula Wound Irrigation Solution is intended for use by healthcare professionals for cleansing, irrigating, moistening, and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full-thickness wounds such as 1st and 2nd degree burns, stage I-IV pressure injuries, diabetic ulcers, stasis ulcers, abrasions and minor skin irritations, post-surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings.

Puracyn Plus Professional Formula Antimicrobial Hydrogel is intended for use by healthcare professionals to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions, as indicated below. Puracyn Plus Professional Formula Antimicrobial Hydrogel relieves itch and pain associated with dermal irritation, sores, injuries, and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. Puracyn Plus Professional Formula Antimicrobial Hydrogel is indicated for the management of partial or full-thickness wounds such as 1st and 2nd degree burns, stage I – IV pressure injuries, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.

Puracyn Plus Professional Formula is manufactured by generating an electrolyte intermediate based on an electrochemical process called electrolysis and formulating the intermediate into the finished product. The basic principle of electrolysis is well established. However, the automation effort to scale up the electrolysis to a well-controlled, commercial manufacturing process is highly complex. A multi-chamber flow system with sophisticated hardware and software design is required. The system is operated by highly trained Innovacyn staff under a cGMP environment. The formulation compounding step is similar to a pharmaceutical manufacturing process. In-process quality control and finished product testing of every production batch assures that high quality standards are met for Puracyn Plus Professional Formula.

• Effective in wound bed preparation
• Safe for irrigation in wound cavities, even with tunneling/undermining wounds
• Debrides both eschar and slough tissue
• Supports reducing/eliminating odor
• Non-cytotoxic
• Non-toxic
• Non-corrosive
• Non-flammable
• Relieves itch and pain of dermal tissues
• Multi-functional
• No special handling
• No special disposal requirements
• Stable; up to two years of storage life
• Ready-to-use
• No dilution required
• No mixing required
• Contains no steroids or antibiotics
• Contains no alcohol or iodine
• Aids in autolytical debridement

The Puracyn Plus bottle may be placed in a warmer up to 40 degrees Celsius (104 degrees Fahrenheit) for up to 30 days, so long as the bottle has at least 6 months until its expiration date when first placed in the warmer. Once taken out of the warmer, the Puracyn bottle should not be re-warmed. The bottle should be used or discarded after 30 days.

Puracyn Plus Professional Formula products are FDA 510(k)-cleared for use on:

• Acute and chronic wounds
• Partial and full-thickness wounds
• Stage I-IV pressure injuries
• Venous stasis ulcers
• Dermatoses (Hydrogel)
• Diabetic ulcers
• Post-surgical wounds
• Trauma wounds
• 1st and 2nd degree burns
• Abrasions and minor irritations of the skin

Puracyn Plus Professional Formula is a family of safe and effective wound irrigation solutions and a hydrogel—an adjuvant to standard wound care protocols practiced by healthcare professionals. Puracyn Plus Professional Formula is indicated for cleansing, irrigating, debriding, and moistening acute and chronic wounds. Puracyn Plus Professional Formula contains hypochlorous acid, generated via an advanced electrolysis process, which functions as a preservative to inhibit the growth of microorganisms in the product. It should be clearly noted that Puracyn Plus Professional Formula is not indicated for inhibiting the growth of microorganisms primarily in the wound bed because the product is cleared as a medical device—not a drug product—in the United States.

The solution can be applied directly to the wound or poured onto absorbent gauze pads being used to cleanse the wound. The solution can also be used to saturate gauze pads which are placed directly onto the wound. Because the solution is not irritating to the wound, it can be applied liberally and repeatedly until the wound is free of any exudate and presents a clean wound bed. It should be left on the wound and not rinsed or wiped off. You may notice that the wound tissue treated with Puracyn Plus Professional Formula becomes pink or “pinkens” with application of the solution. This is a normal and desired outcome. Once the wound bed has been cleaned, continue with next steps in the wound management protocol.

Puracyn Plus Professional Formula Antimicrobial Hydrogel should be used on wounds with little to no exudate. Shake Puracyn Plus Professorial Formula Antimicrobial Hydrogel well before use. After cleansing the wound with Puracyn Plus Professional Formula Wound Irrigation Solution, apply hydrogel directly to the wound. With some wounds, a wound filler may be needed to fill the cavity. Cover wound with appropriate wound dressing that will hold the hydrogel to the wound bed. Change dressing as ordered or when needed.

Puracyn Plus Professional Formula Wound Irrigation Solution is used during wound bed preparation. Both the Wound Irrigation Solution and Antimicrobial Hydrogel should also be used at each dressing change or as directed by prescribing practitioner.

Puracyn Plus Professional Formula Wound Irrigation Solution is a fluid used to clean the wound, which is an initial and critical step in wound management. The solution can be applied directly to the wound with enough force needed to remove exudates and inflammatory debris. The solution can be used to saturate gauze, which is then used to clean or pack the wound, or both. It can also be used to support wound cleansing during sharp debridement or in combination with gauze as mechanical debridement. Puracyn Plus Professional Formula Antimicrobial Hydrogel is a hydrogel used to maintain a moist wound environment, thereby encouraging autolytic debridement of the wound and relieving discomfort (i.e. itch and pain) associated with dermal irritation.

Components in Puracyn Plus Professional Formula do not have a known history of contraindications. Scientific studies have been conducted to verify the safety and compatibility of Puracyn Plus Professional Formula with common advanced wound care products and modalities.

There have not been reported issues with the use of Puracyn Plus Professional Formula on any age of patient population.

Puracyn Plus Professional Formula products are developed as pH-balanced formulations. Each formulation is engineered to maintain a hydrogen ion concentration in the physiological range and is comparable to the pH of blood or water. This pH range makes the product as tissue friendly for human use as water or normal saline solution.

Puracyn Plus Professional Formula does not damage tissues, but rather, is gentle and safe on them. It is free of toxic chemicals. It has passed FDA-mandated testing on tissue sensitivity and toxicity with no irritation reported. In addition, the safety of Puracyn Plus Professional Formula on wound healing has also been verified in a daily, repeated-use study until full-thickness wound defects were healed in vivo.

Puracyn Plus Professional Formula has been scientifically verified to be non-toxic to fibroblasts as one of the FDA product clearance requirements.

Material compatibility of Puracyn Plus Professional Formula with various products commonly used in wound care management has been evaluated (data on file). In addition, excellent compatibility has been reported by healthcare providers with advanced wound care modalities including tissue grafts.

Puracyn Plus Professional Formula is safe for the environment. No special disposal considerations are required.