ISAGEL- alcohol gel 
Coloplast Manufacturing US, LLC

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Isagel®

Drug Facts

Active ingredient

60% v/v Alcohol Denat

Purpose

Antiseptic Healthcare Personnel Handwash

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

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 - 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
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:11701-025-45800 mL in 1 BAG; 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)

Revised: 12/2023
Document Id: 700f0ddd-e5ae-4223-b779-688b0adbb976
Set id: 5be93a24-c644-4e6b-a600-87f0a5a09e5c
Version: 8
Effective Time: 20231214
 
Coloplast Manufacturing US, LLC