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Product NDC Code | 55443-0085 | ||||||||
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Drug Name | Vionex |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | GEL | ||||||||
RxCUI drug identifier | 1053227, 1053230 |
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Application Number | M003 | ||||||||
Labeler Name | Metrex Research, LLC | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredients Purpose Chloroxylenol 0.52%..............................Healthcare personnel handwash VioNex Liquid Soap 4oz Label Uses handwash to help reduce bacteria that potentially can cause disease helps prevent cross contamination by hand contact recommended for repeated use Warnings For external use only When using this product do not use in or near eyes use in a well-ventilated area discontinue use if irritation and redness develop Keep out of reach of children In case of accidental ingestion, seek medical attention or contact a poison control center immediately. Directions Apply 5 mL of palmful of soap to hands and forearms. Directions wet hands and forearms apply 5 mL or palmful of soap to hands and forearms scrub thoroughly for 30 seconds rinse and repeat Other Information store at room temperature for Hospital and Professional Use only Inactive Ingredients Citric Acid, Cocamidopropyl Betaine, DMDM Hydantoin, F DC Blue No.1, FD C Yellow No.5, Fragrance, Glycerin, Glycol Stearate, Lauramide DEA, Methyl Paraben, Nonoxynol-9, PEG- 150 Distearate, Polyquaternium-7, Propyl Paraben, Propylene Glycol, Quaternium-60, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Tetrasodium EDTA and Water Questions or comments? For product or technical informaiton, contact Metrex, Monday to Friday, 6am - 4pm PST at 800-841-1428 or visit our website at www.metrex.com . Uses Healthcare personnel handwash
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply 5 mL of palmful of soap to hands and forearms.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Citric Acid, Cocamidopropyl Betaine, DMDM Hydantoin, F DC Blue No.1, FD C Yellow No.5, Fragrance, Glycerin, Glycol Stearate, Lauramide DEA, Methyl Paraben, Nonoxynol-9, PEG- 150 Distearate, Polyquaternium-7, Propyl Paraben, Propylene Glycol, Quaternium-60, Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Tetrasodium EDTA and Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses handwash to help reduce bacteria that potentially can cause disease helps prevent cross contamination by hand contact recommended for repeated use
Directions wet hands and forearms apply 5 mL or palmful of soap to hands and forearms scrub thoroughly for 30 seconds rinse and repeat
Purpose
Information about the drug product’s indications for use.Uses Healthcare personnel handwash
Spl product data elements
Usually a list of ingredients in a drug product.VioNex Chloroxylenol SODIUM C14-16 OLEFIN SULFONATE CHLOROXYLENOL CHLOROXYLENOL PEG-150 DISTEARATE PROPYLPARABEN PROPYLENE GLYCOL SODIUM CHLORIDE ANHYDROUS CITRIC ACID COCAMIDOPROPYL BETAINE FD&C BLUE NO. 1 POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) NONOXYNOL-9 DMDM HYDANTOIN FD&C YELLOW NO. 5 GLYCERIN GLYCOL STEARATE LAURIC DIETHANOLAMIDE METHYLPARABEN WATER EDETATE SODIUM EDETIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel VioNex antimicrobial liquid soap Healthcare Personnel Handwash VioNex antimicrobial liquid soap is an advanced liquid formula for broad-spectrum germ killing and effective skin cleansing. Manufactured for: METREX RESEARCH 28210 Wick Road Romulus, Michigan 48174 MADE IN USA Reorder No.: Metrex Protecting People fl. oz. ( mL) gallon (fl. oz.) ( Liters) For use in Wall Mount Dispenser (800 mL package only) VioNex Liquid Soap 18oz Label
VioNex Liquid Soap 4oz Label
1 Gal Bottle
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children In case of accidental ingestion, seek medical attention or contact a poison control center immediately. Directions Apply 5 mL of palmful of soap to hands and forearms.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? For product or technical informaiton, contact Metrex, Monday to Friday, 6am - 4pm PST at 800-841-1428 or visit our website at www.metrex.com .
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use in or near eyes use in a well-ventilated area discontinue use if irritation and redness develop
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at room temperature for Hospital and Professional Use only
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API