Label: ISAGEL- alcohol gel

  • NDC Code(s): 11701-025-04, 11701-025-26
  • Packager: Coloplast Manufacturing US, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    60% v/v Alcohol Denat

  • Purpose

    Antiseptic Healthcare Personnel Hand Wash

  • Uses

    For handwashing to decrease bacteria on the skin.

  • 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.

  • 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 ingredients

    carbomer, fragrance, glycereth-26, PEG-12, triethanolamine, water

  • Questions or comments

    Call toll free 1-800-533-0464

  • SPL UNCLASSIFIED SECTION

    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.

  • 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
  • INGREDIENTS AND APPEARANCE
    ISAGEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol600 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11701-025-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2009
    2NDC:11701-025-26621 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00306/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-025)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!