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Hand sanitizer - Medication Information

Product NDC Code 0519-8802
Drug Name

Hand sanitizer

Type Brand
Active Ingredients
Alcohol 578 mg/ml
Route TOPICAL
Dosage Form GEL
Application Number 505G(a)(3)
Labeler Name Steris Corporation
Packages
Package NDC Code Description
0519-8802-13 444 ml in 1 bottle, plastic (0519-8802-13)
0519-8802-41 1000 ml in 1 bottle, plastic (0519-8802-41)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Ethyl Alcohol 65%

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 thoroughly with product and allow to dry without wiping

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients benzophenone-4, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, tocopheryl acetate, water

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 Healthcare Personnel Handwash to decrease bacteria on the skin before contact with patients under medical care or treatment

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Hand Sanitizer Ethyl Alcohol SULISOBENZONE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) GLYCERIN ISOPROPYL MYRISTATE PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE WATER ALCOHOL ALCOHOL

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 NDC 0519-8802-13 Dignity Health Hand Sanitizer Soft N SureAntiseptic Hand Gel Moisturizing Fast Acting 8D02-26 For Hospital and Professional use Only 6542 8D02-XEA (F) (814) NET CONTENTS: 444 mL (15 FL OZ) image description

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.
Other information do not store above 105⁰ F may discolor some fabrics harmful to wood finishes and plastics Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds* Soft' N Sure is a registered trademark of STERIS Corporation. Dignity Health and its logo are tradmarks of Dignity Health Manufactured for: STERIS Corporation 7501 Page Avenue St. Louis, MO 63133 USA 800-548-4873 www.steris.com

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 or Comments 800-548-4873

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 skin irritation develops. If condition persists more than 72 hours consult a doctor.

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 keep out of eyes. In case of contact with eyes, flush thoroughly with water avoid contact with broken skin do not inhale or ingest

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-hands Keep away from heat and flame

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