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Isagel

Medically reviewed on Feb 21, 2018

Dosage form: gel
Ingredients: Alcohol 600mL in 1000mL
Labeler: Coloplast Manufacturing US, LLC
NDC Code: 11701-025

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.

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

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 (ALLYL PENTAERYTHRITOL CROSSLINKED) 
GLYCERETH-26 
POLYETHYLENE GLYCOL 600 
WATER 
Packaging
#Item CodePackage Description
1NDC:11701-025-04118 mL in 1 BOTTLE
2NDC:11701-025-26621 mL in 1 BOTTLE
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(11701-025)

 
Coloplast Manufacturing US, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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