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Foaming advanced antibacterial hand - Medication Information

Product NDC Code 50865-213
Drug Name

Foaming advanced antibacterial hand

Type Brand
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
50865-213-13 3785 ml in 1 bottle, plastic (50865-213-13)
50865-213-17 50 ml in 1 bottle, plastic (50865-213-17)
50865-213-41 1000 ml in 1 bag (50865-213-41)
50865-213-50 1200 ml in 1 bag (50865-213-50)
50865-213-52 1000 ml in 1 bottle, plastic (50865-213-52)
50865-213-78 950 ml in 1 bottle, plastic (50865-213-78)
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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 the skin, apply a 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 betaine, cocamidopropyl PG-dimonium chloride phosphate, PEG-6 cocamide, laurtrimonium chloride, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), fragrance, iodopropynyl butylcarbamade, methylisothiazolinone, yellow 5, red 33.

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 Handwash to help 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.
Foaming Advanced Antibacterial Hand benzalkonium chloride WATER COCAMIDOPROPYL BETAINE COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE PEG-6 COCAMIDE LAURTRIMONIUM CHLORIDE METHYLISOTHIAZOLINONE IODOPROPYNYL BUTYLCARBAMATE FD&C YELLOW NO. 5 D&C RED NO. 33 ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE 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.
image description image description image description image description image description

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.

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 eye contact occurs, flush eyes with water. Stop use if , in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.

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