FDA.reportPublic FDA data

Isagel

Manufacturer
Coloplast Corp | Medline Industries, LP
Effective date
2026-03-27
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 01:51:55

Label at a glance#

ProductIsagel
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

For handwashing to decrease bacteria on the skin.

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

60% v/v Alcohol Denat

Purpose

OTC - PURPOSE SECTION

Antiseptic Healthcare Personnel Hand Wash

Uses

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes. If eye contact occurs, flush with water.

OTC - STOP USE SECTION

Stop using this product

  • if skin irritation and redness develop
  • if condition persists for more than 72 hours, consult a physician.

SPL UNCLASSIFIED SECTION

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions or comments

OTC - QUESTIONS SECTION

Call toll free 1-800-533-0464

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 118 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581658ethanol 60 % Topical GelPSN13
581658ethanol 0.6 ML/ML Topical GelSCD13
581658ethanol 60 % Topical GelSY13

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11701-025-042023-12-15C16284748780-1f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®
11701-025-262023-12-15C16284748780-1f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®
11701-025-042023-01-30C16284748780-1f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®
11701-025-262023-01-30C16284748780-1f386c649-b6e2-0266-e053-dadaa90a7c1aISAGEL ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-025-04Isagel118 mL in 1 BOTTLEGEL11813
11701-025-26Isagel621 mL in 1 BOTTLEGEL62113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-025-03ML - Milliliter11701-025fa5a4032-4c9c-46af-b1be-aa7bfa3ac1b712015-10-02
11701-025-04ML - Milliliter11701-0255664161c-2ef1-42b2-98e8-8142c5ec75f112013-02-13
11701-025-26ML - Milliliter11701-02591007fbc-1352-4650-ab69-c33e888ffd8412013-02-13
11701-025-45ML - Milliliter11701-0250996711d-75a2-4450-a230-b1f45b32158e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M7
AlcoholACTIVE MOIETY3K9958V90M7
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27E7
GLYCERETH-26INACTIVE INGREDIENTNNE56F2N147
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N97
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK7
WATERINACTIVE INGREDIENT059QF0KO0R7

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11701-02511701-025-04, 11701-025-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
GLYCERETH-26NNE56F2N14IACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9SOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
3 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9SOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POLYETHYLENE GLYCOL 600POLYETHYLENE GLYCOL 600NL4J9F21N9SOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IsagelALCOHOLColoplast Corpeba7e574-25c2-445a-98f6-2d10454554662026-03-27WarningsExact identifier
ndc (package): 11701-025-04
ndc (package): 11701-025-26
ndc (product): 11701-025
ndc11 (package): 11701002526
ndc11 (package): 11701002504
spl id: 48028c1c-0707-4208-8c36-ae2b25f3a59d
spl set id: eba7e574-25c2-445a-98f6-2d1045455466
IsagelALCOHOLColoplast Corp5be93a24-c644-4e6b-a600-87f0a5a09e5c2026-03-27WarningsExact identifier
ndc (product): 11701-025

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.