ION GEL ZCM-25® User Manual

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

Medical Device
Ion Gel ZCM-25®

Generic Name

Cationic minerals

Description

An ionic amine redox solution based on Zinc, Copper, Magnesium, Sulfur and Hydrogen formulated in a unique aqueous ligand system (Hexa-aqua) for a topical transport mechanism.

Intended Uses

Ion Gel ZCM-25® has been proven to support the wound healing process. Its active ingredient with high oxidative redox potential increases antioxidant effects through the reduction of reactive oxygen species (ROS), decreases healing time, reduces pH and provides antimicrobial effects for infection prevention. Multiple tests performed on the product support its antibacterial (including tests with multi-resistant strains), antiviral, antifungal and antibiofilm activity.

INSTRUCTIONS FOR USE

Application

• Using the cone tip dispenser and a surgical glove or a clean finger, apply evenly a coating of approximately 0.50 mm thick of Ion Gel ZCM-25®, around an open wound, with a margin of 10.00 mm away from an open wound; or directly on the wound, only if it is closed or crusted.
• Do not use a metal applicator or allow Ion Gel ZCM-25® to come in contact with any metal.
• Do not use latex gloves to apply Ion Gel ZMC-25® or allow it to come into contact with latex.
• Allow the formula to absorb into the skin naturally; there is no need to “rub” it into the skin; it should be completely absorbed within 2 minutes.
• Once absorbed, apply additional dressings as prescribed by your physician.

General Protocol

• After each wound healing period, repeat the application.
• Continue applications 2 times per day, or as prescribed by your treating physician.
• Best results generally occur after 2 to 4 weeks of continuous use.
• Discontinue use when determined by your reviewing physician.

Container Presentations

• Ion Gel ZCM-25® Medication Storage Container - Dispensing Tube.
• Ion Gel ZCM-25® Secondary Packaging - Outer Carton Packaging.
• Ion Gel ZCM-25® Manual - Printed Instruction Insert.

Storage Requirements

Store this product out of direct sunlight from 5 ºC to 32 ºC (40 ºF - 90 ºF). Reseal the storage container with its lid after each use.

Safety Precautions

• Ion Gel ZCM-25® contains a lower pH than normal topical preparations. If you have sensitive skin, patch test on one arm for 1 to 30 minutes before longer use.
• Consult your physician if you have intolerance to Zinc, Copper, Magnesium, Amine and Sulfur due to known allergies.
• Avoid contact with eyes and sensitive membranes; if the product accidentally comes into contact with these areas, rinse thoroughly with plenty of water.
• Do not use this formula if you are pregnant or in children under 2 years old. Consult your physician regarding use in children under 18 years old.
• You may experience a slight burning sensation which is normal and is related to the way it works. With regular use, this sensation may disappear.
• Do not apply heat to the area immediately before or after use.
• If prescription medications are being taken, read the information accompanying those medications to make sure there are no contraindications to any of the components listed in the technical data sheet.
• Stop use and consult your physician if the condition worsens, does not improve after continued use, persistence of burning persists, blistering occurs, or difficulty in breathing or swallowing occurs.

Warnings

For external use only. Avoid contact with mucous membranes. Do not ingest or use internally; If swallowed, get medical help or contact a Poison Control Center immediately.

Adverse Events

The use of Ion Gel ZCM-25® on open wounds may cause burning. Report all adverse events to [email protected] or telephone +52-322-221-1057, and to Ion Biotechnology México, S.A. de C.V. at Plaza Marina Local D24, Marina Vallarta, C.P. 48335 Puerto Vallarta, Jalisco Mexico +52-322-221-1057 or visit https://ionbiotech.mx/adverse-reaction/

Medical Device Information Panel

Ion Gel ZCM-25®, Cont. 10 grams, Topical Antimicrobial. Reg. No. 0239C2021 SSA

Made in Mexico by: 

Laboratorios Zeyco S.A. de C.V. 

Camino a Sta. Ana Tepetitlán No. 2230-C, Col. Santa Ana Tepetitlán, C.P. 45230, Zapopan, Jalisco, México. 

For:

Ion Biotechnology México, S.A. de C. V. 

Blvd. Fco. Medina Ascencio 3975 lnt. D24, Col. Marina Vallarta, C.P. 48335, Puerto Vallarta, Jalisco, México. 

Indications for use: Antimicrobial topical gel to prevent infections and promote wound healing.Plaza Marina Local D24, Marina Vallarta, C.P. 48335. Puerto Vallarta, Jalisco, México.