Isagel by Coloplast Manufacturing US, LLC / Coloplast Corp ISAGEL- alcohol gel

Isagel by

Drug Labeling and Warnings

Isagel by is a Otc medication manufactured, distributed, or labeled by Coloplast Manufacturing US, LLC, Coloplast Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 60% v/v

Purpose

Antiseptic 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.

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

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

Manufactured by/Fabriqué pan Coloplast A/S
DK-3050 Humlebaek, Denmark
Distributed by/Distribué par: Coloplast Corp.
Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.us.coloplast.com
Coloplast Canada Corp. Mississauga ON L5L 5Z9
1-888-880-8605 www.coloplast.ca
Product/Producit #7041 ©2008-10, Coloplast Corp.
Made in the U.SA/Fabriqué aux Etats-Unis

DSP-MN-38

K8-842

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 800 mL (27 fl. oz.)

NDC: 11701-025-45

Sween®

ISAGEL®

Latex Glove and CHG Compatible

ETHYL ALCOHOL

NO-RINSE, ANTISEPTIC

HAND CLEANSING GEL

WITH ADDED

MOISTURIZERS

Coloplast

800 mL (27 fl. oz.)

INGREDIENTS AND APPEARANCE

ISAGEL   B-I-B
alcohol gel

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	600 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
GLYCERETH-26 (UNII: NNE56F2N14)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11701-025-45	800 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/15/2009

Labeler - Coloplast Manufacturing US, LLC (110326675)

Registrant - Coloplast Corp (847436391)

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