ISAGEL - alcohol gel 
Coloplast Manufacturing US, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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For Healthcare Personnel Handwashing

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 with product and allow to dry without wiping.

Inactive ingredients

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

Meets the CDC Hand Hygiene Guideline in healthcare settings. For use when hands are not visibly soiled.

Manufactured by: Coloplast A/S
DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp.
Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.us.coloplast.com
Product #1645 ©2009-2, Coloplast Corp.
Made in the U.S.A.

DSP-MN-38

NDC 11701-025-04

Latex Clove and CHG Compatible

Isagel®

Handwashing

No-Rinse, Antiseptic Hand Cleansing Gel with Added Moisturizers

For Healthcare Personnel Handwashing

Coloplast

4 fl. oz. (118 mL) B9-1111

PRINCIPAL DISPLAY PANEL - 21 fl. oz. (621 mL)

ISAGEL  
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11701-025
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL600 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE 
CARBOMER HOMOPOLYMER TYPE C 
GLYCERETH-26 
POLYETHYLENE GLYCOL 600 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:11701-025-0359 mL in 1 BOTTLENone
2NDC:11701-025-04118 mL in 1 BOTTLENone
3NDC:11701-025-26621 mL in 1 BOTTLENone

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/FEIOperations
Coloplast Manufacturing US, LLC110326675MANUFACTURE

Revised: 06/2011 Coloplast Manufacturing US, LLC