Isagel
FDA Label NDC 11701-025

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Coloplast Corp for the product Isagel (NDC 11701-025). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, stop using this product, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Principal Display Panel (800 mL Bag Label)

Principal Display Panel (800 mL Bag Label)

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