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 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

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
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)

Revised: 12/2023
Document Id: b22de22e-e46c-445c-bb8a-533c6392b7e7
Set id: eba7e574-25c2-445a-98f6-2d1045455466
Version: 11
Effective Time: 20231214
 
Coloplast Manufacturing US, LLC