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Isagel - Medication Information

Product NDC Code 11701-025
Drug Name

Isagel

Type Brand
Active Ingredients
Alcohol 600 ml/1000ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 581658
Application Number M003
Labeler Name Coloplast Manufacturing US, LLC
Packages
Package NDC Code Description
11701-025-04 118 ml in 1 bottle (11701-025-04)
11701-025-26 621 ml in 1 bottle (11701-025-26)
11701-025-45 800 ml in 1 bag (11701-025-45)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient 60% v/v Alcohol Denat

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. Rub product into hands and allow to dry. Do not rinse. Wash hands with water and hand cleanser after every 7-9 applications. For use when hands are not visibly soiled.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients carbomer, fragrance, glycereth-26, PEG-12, triethanolamine, 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 For handwashing to decrease bacteria on the skin.

Purpose

Information about the drug product’s indications for use.
Purpose Antiseptic Healthcare Personnel Hand Wash

Spl product data elements

Usually a list of ingredients in a drug product.
Isagel Alcohol Alcohol Alcohol TROLAMINE CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) GLYCERETH-26 POLYETHYLENE GLYCOL 600 WATER

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 - 118 mL Bottle Label NDC 11701-025-04 Latex Glove and CHG Compatible Isagel ® Handwashing No-Rinse, Antiseptic Hand Cleansing Gel with Added Moisturizers For Healthcare Personnel Handwashing Product #1644 Coloplast 4 fl. oz. (118 mL) F15-1111 Principal Display Panel - 118 mL Bottle Label

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.
Drug Facts Manufactured by: Coloplast A/S Holtedam 1 DK-3050 Humlebaek, Denmark Distributed by: Coloplast Corp. 1601 W River Rd N Minneapolis, MN 55411 U.S.A.

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 this and all drugs 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 Call toll free 1-800-533-0464

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 using this product if skin irritation and redness develop if condition persists for more than 72 hours, consult a physician.

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 avoid contact with eyes. If eye contact occurs, flush with water.

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 Flammable, keep away from fire or flame. When using this product avoid contact with eyes. If eye contact occurs, flush with water. Stop using this product if skin irritation and redness develop if condition persists for more than 72 hours, consult a physician. For external use only. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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