Label: ULTRACARE FOR HANDS- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 22, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Use hand sanitizer to reduce bacteria on the skin.

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Place enough product in palm to thoroughly cover all surfaces of both hands

    Rub hands together briskly until dry

    No rinsing required

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid

  • PRINCIPAL DISPLAY PANEL

    Ultracare

    For Hands

    Alcohol Free Antiseptic Handwash

    Formulated to reduce the number of germs on the hands that can cause infection and illness.

    Use on clean, non-soiled hands any time when rinsing with water is not available.

    Alcohol free, so it can be used in any area without fear of it creating a flammable atmosphere.

    Manufactured for

    Ultronics

    Cuyahoga Falls, OH 44223

    www.UltronicsUSA.com  Tel. (800) 262-6262

    1000 ml  33.8 fl. oz.  Made in USA  P/N

    container label

  • INGREDIENTS AND APPEARANCE
    ULTRACARE FOR HANDS 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51614-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51614-0001-11000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2012
    Labeler - Coltene Whaledent Inc (622185718)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture
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