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| Product NDC Code | 68196-665 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Antibacterial |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SOLUTION | ||||||
| RxCUI drug identifier | 1046593 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | Sam's West, Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium Chloride (0.13%)
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 • Wet hands • Apply 5mL (teaspoonful) or palmful to hands and forearms • Rub vigorously for 20 seconds • Wash between fingers, around fingernails and backs of hands • Rinse thoroughly with warm water • Dry with paper towels or air-dry
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Cetrimonium chloride, Lauramine oxide, Cocamide MIPA, Lauramidopropylamine oxide, Sodium benzoate, PEG-120 methyl glucose dioleate, Citric acid, Glycerin, Sodium chloride, Fragrance, Disodium EDTA, Red 40.
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 For handwashing to decrease bacteria on skin
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic Handwash
Spl product data elements
Usually a list of ingredients in a drug product.Antibacterial Benzalkonium Chloride BENZALKONIUM CHLORIDE BENZALKONIUM GLYCERIN SODIUM BENZOATE WATER LAURAMIDOPROPYLAMINE OXIDE PEG-120 METHYL GLUCOSE DIOLEATE EDETATE DISODIUM LAURAMINE OXIDE CETRIMONIUM CHLORIDE COCAMIDE MIPA RED 40 SODIUM CHLORIDE ANHYDROUS CITRIC 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.NDC 68196-665-01 1 GALLON M Member's Mark™ ANTIBACTERIAL HAND SOAP COMMERCIAL GRADE KILLS 99.9% OF GERMS* FRESH CLEAN FRAGRANCE NET CONTENTS 1 GALLON (3.78 L) container label container label container label container label
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 • In eyes
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, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • For additional information, see Safety Data Sheet (SDS) • For emergency medical information, call 1-866-767-5045
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 ask a doctor if Skin irritation or redness occurs 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 If in eyes, rinse promptly and thoroughly with water Discontinue use if irritation and redness develop
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 Do not use • In eyes When using this product If in eyes, rinse promptly and thoroughly with water Discontinue use if irritation and redness develop Stop use and ask a doctor if Skin irritation or redness occurs for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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