ISAGEL - alcohol gel 
Coloplast Manufacturing US, LLC

----------

Isagel®
Handwashing
No-Rinse, Antiseptic Hand Cleansing Gel with Added Moisturizers

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

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

NDC 11701-025-26

Latex Clove and CHG Compatible

Isagel®

Handwashing

No-Rinse, Antiseptic Hand Cleansing Gel with Added Moisturizers

For Healthcare Personnel Handwashing

Coloplast

21 fl. oz. (621 mL)

ISAGEL   alcohol   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11701-025 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 600 mL  in 1000 mL

Inactive Ingredients Ingredient Name Strength TROLAMINE   CARBOMER HOMOPOLYMER TYPE C   POLYETHYLENE GLYCOL 600   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11701-025-03 59 mL In 1 BOTTLE None 2 11701-025-04 118 mL In 1 BOTTLE None 3 11701-025-26 621 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

Establishment
Name	Address	ID/FEI	Operations
Coloplast Manufacturing US, LLC		110326675	MANUFACTURE

Revised: 06/2010Coloplast Manufacturing US, LLC