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Antibacterial - Medication Information

Product NDC Code 65321-031
Drug Name

Antibacterial

Type Brand
Active Ingredients
Benzalkonium chloride 13 mg/10ml
Route TOPICAL
Dosage Form SOAP
RxCUI drug identifier 1046593
Application Number M003
Labeler Name Rubbermaid Commercial Products LLC
Packages
Package NDC Code Description
65321-031-01 800 ml in 1 bottle, pump (65321-031-01)
65321-031-02 1600 ml in 1 bottle, pump (65321-031-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient 0.13% Benzalkonium Chloride

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, place hands under the dispenser to allow 0.8ml of hand wash to squirt into hands, wash thoroughly for at least 30 seconds, rinse hands thoroughly with potable water after washing.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, Cetrimonium Chloride, Glycerin, Sodium Chloride, Lauramidopropylamine Oxide, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazilinone, Methylisothiazilinone.

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 hand washing to decrease bacteria on skin. Repeat as needed.

Purpose

Information about the drug product’s indications for use.
Purpose Antibacterial Hand Wash

Spl product data elements

Usually a list of ingredients in a drug product.
Antibacterial Benzalkonium Chloride Benzalkonium Chloride Benzalkonium Water Cetrimonium Chloride Glycerin Sodium Chloride Lauramidopropylamine Oxide Coco Monoethanolamide PEG-120 Methyl Glucose Dioleate Citric Acid Monohydrate Edetate Sodium METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE

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 - 800 mL Bottle Label Rubbermaid ® Commercial Products T ECHNICAL C ONCEPTS Antibacterial Lotion Soap To be used with OneShot ® liquid dispensers 800mL (27 FL. OZ.) PRINCIPAL DISPLAY PANEL - 800 mL Bottle 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 Distributed by Rubbermaid Commercial Products LLC 3124 Valley Avenue, Winchester, VA U.S.A. 22601-2694

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-800-347-9800 Mon – Fri, 8 AM – 5 PM EST

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 irritation or redness persist.

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 . In case of eye contact, flush 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 . In case of eye contact, flush with water. Stop use and ask a doctor, if irritation or redness persist. Do not ingest. 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