ULTRACARE FOR HANDS (BENZALKONIUM CHLORIDE) LIQUID [COLTENE WHALEDENT INC]

ULTRACARE FOR HANDS (BENZALKONIUM CHLORIDE) LIQUID [COLTENE WHALEDENT INC]
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NDC 51614-0001-1
Set ID fd2aedd4-1fae-43b3-8a53-3effe38212c8
Category HUMAN OTC DRUG LABEL
Packager Coltene Whaledent Inc
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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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