ION GEL ZCM-25® User Manual

ION GEL ZCM-25® User Manual in Spanish and English

Medical Device Name

Ion Gel ZCM-25®

Description

A redox solution of ionic amine, zinc, copper, magnesium, sulfur, and hydrogen in a water ligand system formulated in a topical pharmaceutical carrying mechanism of Sepineo Derm, sodium hyaluronate, and glycerin.

Intended Uses 

Ion Gel ZCM-25® in clinical studies has shown to increase wound healing, lessen healing time, reduce the pH of the skin, and provide antimicrobial effects for infection prevention. A topically systemic application of micro-nutritional and anti-inflammatory benefits to enhance tissue rejuvenation. A Redox Medicine that increases antioxidant effects through Reactive Oxygen Species (ROS) reduction.

Instructions for Use

Application

• Using the cone tip dispenser and a surgical glove or a clean finger, liberally and evenly apply approximately a 0.50 mm thick coating of Ion Gel ZCM-25® extending 10.00 mm around an open wound, or directly on an affected area.
• Do not use a metal applicator or allow the Ion Gel ZCM-25® to come in contact with metal.
• Do not use latex gloves when applying Ion Gel ZCM-25® nor allow it to come in contact with latex.
• Allow the formula to be absorbed into the skin naturally; it is not necessary to “rub” it into the skin; it should be completely absorbed within 2 minutes.
• Once absorbed apply any additional dressings as prescribed by your physician.

General Protocol

• Upon each wound redressing period repeat application.
• Continue applications after the bandage period 2 times per day.
• Best results typically occur after 2 to 4 weeks of continued use.
• Discontinue use when determined by your physician’s review.

Container Presentations 

• Ion Gel ZCM-25® Drug Storage Container - Tube Dispenser
• Ion Gel ZCM-25® Container - Outside Box Packaging
• Ion Gel ZCM-25® Manual - Printed Directions Insert

Storage Requirements

Store this product out of direct sunlight between 5º-32º Celsius (40F-90F). Close the storage container with it's cap after each use.

Safety Precautions 

• Ion Gel ZCM-25® contains a lower Ph than normal topical preparations and if you have sensitive skin, do a patch test on your arm for 1 to 30 minutes prior to extended use.
• Consult with your physician for intolerance to Zinc, Copper, Magnesium, Amine, and Sulfur for known allergies.
• Keep out of eyes and sensitive membranes; If you do get the product in these areas, rinse thoroughly with water.
• Do not use this formula if you are pregnant or with children under 2 years of age. Consult your Physician on all children under 18 years of age.
• You may experience a slight burning sensation which is normal and related to the way it works. With regular use, this sensation may go away.
• Do not apply heat to the area immediately before or after use.
• If you are taking prescription drugs, read the information which accompanied those drugs to ensure that there are no contraindications of the ingredients listed below on the Drug Facts Panel.
• Stop use and consult with your physician if the condition worsens, does not improve after continued use, severe burning persists, blisters occur, or difficulty breathing or swallowing.

Warnings 

For External Use Only. Do not swallow or use internally; If swallowed, get medical help or contact a Poison Control Center immediately.

Adverse Events

The use of Ion ZCM-25® on open wounds may create a stinging effect. Report all adverse events to [email protected], or to Ion Biotechnology México, S.A. de C.V. at Plaza Marina Local D24, Marina Vallarta, C.P. 48335 Puerto Vallarta, Jalisco Mexico.

Phone: +52-322-221-1057 or visit https://ionbiotech.mx/adverse-reaction/

Medical Device Facts Panel

Ion Gel ZCM-25®, Net Wt. 10 grams, Topical Antimicrobial Wound Dressing

Made in Mexico by:

LABORATORIOS MANUELL S.A.

Jarciería No. 237, Col. Morelos, C.P. 15940, Deleg. Venustiano Carranza, Ciudad de México, México

For:

ION BIOTECHNOLOGY MÉXICO S.A. de C.V.

Plaza Marina Local D24, Marina Vallarta, C.P. 48335. Puerto Vallarta, Jalisco, México.