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Product NDC Code | 69446-220 | ||||
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Drug Name | Hand sanitizing wipes |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CLOTH | ||||
RxCUI drug identifier | 1038856 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Ez Products Of South Florida, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium Chloride (BZK) 0.1% Purpose Antibacterial
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 1. Locate tear-notch on the side of pouch. 2. Tear straight across to open. 3. Pull first wipe from center of roll and thread wipe through dispensing nozzle Do not remove wipes roll from pouch.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients 2-Bromo-2-Nitropropane-1,3-Diol, Alcohol,Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Citric Acid, Fragrance, Iodopropynyl Butylcarbamate, Lauryl Glucoside, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, 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.Use Decrease bacteria on the skin.
Purpose
Information about the drug product’s indications for use.Purpose Antibacterial
Spl product data elements
Usually a list of ingredients in a drug product.Hand Sanitizing Wipes BENZALKONIUM CHLORIDE BRONOPOL ALCOHOL ALOE VERA LEAF CHAMOMILE CITRIC ACID MONOHYDRATE IODOPROPYNYL BUTYLCARBAMATE LAURYL GLUCOSIDE PHENOXYETHANOL PROPYLENE GLYCOL EDETATE SODIUM 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 Labeling: Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information Dispose of wipe in the proper container. Do not flush down the toilet.
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 if irritation and redness develop.
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. If swallowed, seek medical attention or contact Poison Control Center.
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 and seek medical attention if condition persists for more than 72 hours.
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 avoid contact with eyes.If contact occurs, rinse thoroughly with water.
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. When using this product avoid contact with eyes.If contact occurs, rinse thoroughly with water. Do not use if irritation and redness develop. Stop use and seek medical attention if condition persists for more than 72 hours. Keep out of reach of children. If swallowed, seek medical attention or contact Poison Control Center.
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