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Product NDC Code | 50865-017 | ||||||||||||||
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Drug Name | E2 sanitizing hand |
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Type | Generic | ||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||
Dosage Form | SOAP | ||||||||||||||
Application Number | 505G(a)(3) | ||||||||||||||
Labeler Name | KUTOL PRODUCTS COMPANY | ||||||||||||||
Packages |
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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