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| Product NDC Code | 11701-025 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Isagel |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| RxCUI drug identifier | 581658 | ||||||||
| Application Number | M003 | ||||||||
| Labeler Name | Coloplast Manufacturing US, LLC | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 Handwash
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 - 800 mL Bag Label NDC 11701-025-45 Latex Glove and CHG Compatible Isagel ® Handwashing No-Rinse, Antiseptic Hand Cleansing Gel with Added Moisturizers For Healthcare Personnel Handwashing Product #7041 Coloplast 27 fl. oz. (800 mL) PRINCIPAL DISPLAY PANEL - 800 mL Bag 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. For external use only.
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