FDA Label for Isagel

View Indications, Usage & Precautions

Isagel Product Label

The following document was submitted to the FDA by the labeler of this product Coloplast Manufacturing Us, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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.


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.


Otc - Keep Out Of Reach Of Children



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


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)


* Please review the disclaimer below.