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Antibacterial hand cleanser - Medication Information

Product NDC Code 66608-215
Drug Name

Antibacterial hand cleanser

Type Brand
Active Ingredients
Benzalkonium chloride .013 mg/ml
Route TOPICAL
Dosage Form SOAP
Application Number 505G(a)(3)
Labeler Name Kimball Midwest
Packages
Package NDC Code Description
66608-215-09 3785 ml in 1 bottle (66608-215-09)
66608-215-65 800 ml in 1 bag (66608-215-65)
66608-215-78 1000 ml in 1 bottle (66608-215-78)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Section 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.
Dosage and Administration Directions Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse. Children under 6 years of age should be supervised when using this product.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient Section Inactive Ingredients Water, Cetrimonium Chloride, Lauramine Oxide, Sorbitol, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Sodium Lauraminodipropionate, Citric Acid, Fragrance, Disodium EDTA, Methyllisothiazolinone, Methylchloroisothiazolinone, 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.
Indications and Usage Section Uses Handwash to help decrease bacteria on skin.

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Antibacterial Hand Cleanser Benzalkonium Chloride METHYLISOTHIAZOLINONE METHYLCHLOROISOTHIAZOLINONE COCOYL METHYL MONOETHANOLAMINE FD&C YELLOW NO. 5 ACID RED 35 WATER CETRIMONIUM CHLORIDE SORBITOL PEG-120 METHYL GLUCOSE DIOLEATE CITRIC ACID ACETATE SODIUM CHLORIDE LAURAMINE OXIDE DISODIUM EDTA-COPPER CUPRIC CATION SODIUM LAURIMINODIPROPIONATE 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.
Principal Display Label Pricipal Label Display

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 Section Keep Out Of Reach Of Children If swallowed, get medical help or contact a Poison Control Center right away.

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 Section Warnings For external use only. Do not use in eyes. In case of contact, immediately flush with water. Stop use and ask a doctor if irritation or rash appears and lasts.

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