ISAGEL- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

Coloplast Manufacturing US, LLC

INN (International Name):

ALCOHOL

Composition:

ALCOHOL 600 mL in 1000 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic Healthcare Personnel Handwash For handwashing to decrease bacteria on the skin.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ISAGEL- ALCOHOL GEL
COLOPLAST MANUFACTURING US, LLC
----------
ISAGEL
_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. 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 - 800 ML BAG LABEL
NDC 11701-025-45
Latex Glove
and CHG Compatible
Isagel
Handwashing
No-Rinse,
Antiseptic Hand
Cleansing Gel
with Added
Moisturizers
For Healthcare
Personnel
Handwashing
Product #7041
Coloplast
27 fl. oz. (800 mL)
®
ISAGEL
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)
Coloplast Manufacturing US, LLC
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII:
4Q93RCW27E)
GLYCERETH-26 (UNII: NNE56F2N14)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING