ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]

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ISAGEL (ALCOHOL) GEL [COLOPLAST MANUFACTURING US, LLC]
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NDC 11701-025-04, 11701-025-26
Set ID eba7e574-25c2-445a-98f6-2d1045455466
Category HUMAN OTC DRUG LABEL
Packager Coloplast Manufacturing US, LLC
Generic Name
Product Class
Product Number
Application Number PART333E
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  • 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 not finalpart333E06/15/2009
    Labeler - Coloplast Manufacturing US, LLC (110326675)
    Registrant - Coloplast Corp (847436391)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coloplast Manufacturing US, LLC110326675MANUFACTURE(11701-025)
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