Label: ULTRACRUZ ANTIBACTERIAL HAND NONE- benzalkonium chloride soap

  • 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 August 22, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose:

    Antiseptic

  • INDICATIONS & USAGE

    Uses:

    For hand washing to kill bacterial on the skin

  • WARNINGS

    Warnings

    For external use only

    Flammable. Keep away from fire or flame

    Do not apply around eyes. Do not use in ears & mouth

    When using this product, avoid contatc with eyes. In case of contact, flush eyes with water

  • STOP USE

    Stop use and see a doctor if irritation or redness develop and persist for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • DOSAGE & ADMINISTRATION

    Directions:

    Wet hands, apply to palms, scrub thoroughly, then rinse.

  • OTHER SAFETY INFORMATION

    Other Information:

    Store at 20C (68-77F). May discolor fabrics

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Deionized water, Sodium lauryl polyoxyehthylene ether sulfate, Sodium fatty alcohol ethyl sulfate, Cocoamidoprophyl

    betaine, Carboxylmethylcellulose sodium, DMDM Hydantoin, Glycerol, Frangance

  • PRINCIPAL DISPLAY PANEL

    label picture

  • INGREDIENTS AND APPEARANCE
    ULTRACRUZ ANTIBACTERIAL HAND  NONE
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49877-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 72.525 g  in 100 mL
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49877-012-01237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/22/2014
    Labeler - Cixi Zhixin Bird Clean-care Product Co., Ltd. (529823986)
    Registrant - Cixi Zhixin Bird Clean-care Product Co., Ltd. (529823986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cixi Zhixin Bird Clean-care Product Co., Ltd.529823986manufacture(49877-012)
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