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Product NDC Code | 78128-101 | ||||
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Drug Name | Juc sterilization wipes |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CLOTH | ||||
Application Number | part333E | ||||
Labeler Name | NMS Technologies Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium chloride 3mg/mL. Purpose: Antimicrobial
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 Unpack and unfold the wipes. From one side of the skin or surface of the object, wipe orderly to cover the entire surface.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient 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.Indications & usage This product can be directly wiped to form a physical antimicrobial film to kill Escherichia coli, Staphylococcus aureus.
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial.
Spl product data elements
Usually a list of ingredients in a drug product.JUC Sterilization Wipes Wipes WATER BENZALKONIUM CHLORIDE BENZALKONIUM
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.Package label. Principal display panel W080
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use Do not replace wipes used for medical procedures.
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 This product should be placed out of reach of children.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use Stop use if there is discomfort, please immediately seek medical attention.
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 avoid direct contact with eyes and damaged skin.
Storage and handling
Information about safe storage and handling of the drug product.Other information Storage: Avoids light, sealed and stored in a cool place.
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 This product avoids direct contact with eyes and damaged skin.
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