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E2 sanitizing hand - Medication Information

Product NDC Code 50865-017
Drug Name

E2 sanitizing hand

Type Generic
Active Ingredients
Benzalkonium chloride .003 mg/ml
Route TOPICAL
Dosage Form SOAP
Application Number part333A
Labeler Name KUTOL PRODUCTS COMPANY
Packages
Package NDC Code Description
50865-017-03 209000 ml in 1 drum (50865-017-03)
50865-017-07 4000 ml in 1 bottle, plastic (50865-017-07)
50865-017-09 4000 ml in 1 bottle, plastic (50865-017-09)
50865-017-41 1000 ml in 1 bag (50865-017-41)
50865-017-65 800 ml in 1 bag (50865-017-65)
50865-017-67 2000 ml in 1 bottle, plastic (50865-017-67)
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Active ingredient

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

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 To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Hydroxyethyl Cellulose, Laurtrimonium Chloride, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

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 For handwashing to help reduce bacteria on the skin that could cause disease.

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
E2 SANITIZING HAND E2 SANITIZING HAND WATER COCAMIDOPROPYL BETAINE COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE PEG-6 COCAMIDE HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) LAURTRIMONIUM CHLORIDE METHYLISOTHIAZOLINONE IODOPROPYNYL BUTYLCARBAMATE 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.
1703 label 1703 label 1707 label 1707 label 1709 label 1709 label 1765 label 1765 label 1767 label 1767 label

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, contact a physician or poison control center.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Kutol Product Co. Cincinnati, OH 45241 www.Kutol.com

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, in rare instances, redness or irritation develops and persists for more than 72 hours.

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. Avoid contact with eyes. If contact occurs, flush with water. Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours. Keep out of reach of children. If swallowed, contact a physician or 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