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Name:Non-aerosol Antimicrobial Foam Hand Rub
Manufacturer:Ecolab Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NON-AEROSOL ANTIMICROBIAL FOAM HAND RUB  - benzalkonium chloride solution 
Ecolab Inc.

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.

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Drug Facts

Active Ingredient

Benzalkonium chloride 0.1%

Purpose

Antiseptic handwash

Uses

  • for handwashing to decrease bacteria on the skin

Warnings

  • For external use only
  • Avoid contact with eyes.  In case of contact, immediately flush eyes with cool running water.

Do not use

  • In eyes

When using this product

  • discontinue use if irritation and redness develop

Stop use and ask doctor if

  • Skin irritation and redness develop

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Spread thoroughly on hands and rub until dry
  • Use as part of your daily cleansing routine

Other information

  • For additional information, see Material Safety Data Sheet (MSDS)
  • For emergency medical information in USA and Canada, call 1-800-328-0026

Inactive ingredients

FDC Blue 1, FDC Red 40, isopropyl alcohol, propylene glycol, water

Questions?

Call 1.866.781.8787

Principal Display Panel/Representative Label



ECOLAB

Non-Aerosol Antimicrobial Foam Hand Rub


0.1% Benzalkonium chloride liquid

  • One-step procedure, no rinse required.
DIN 02299747
Net Content:  25 U.S. fl. oz (750 mL)

Ecolab Healthcare Division
370 Wabasha Street N., St. Paul, MN 55102


Representative label


NON-AEROSOL ANTIMICROBIAL FOAM HAND RUB 
antiseptic handwash solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47593-454
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM ) BENZALKONIUM CHLORIDE 0.1 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47593-454-41 750 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 01/15/2008

Labeler - Ecolab Inc. (006154611)

Revised: 10/2009 Ecolab Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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