ULTRACRUZ ANTIBACTERIAL NONE (BENZALKONIUM CHLORIDE) LOTION [CIXI ZHIXIN BIRD CLEAN-CARE PRODUCT CO., LTD.]

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ULTRACRUZ ANTIBACTERIAL NONE (BENZALKONIUM CHLORIDE) LOTION [CIXI ZHIXIN BIRD CLEAN-CARE PRODUCT CO., LTD.]
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NDC 49877-011-01
Set ID e3111c78-df33-419a-af35-294ea586b0d8
Category HUMAN OTC DRUG LABEL
Packager Cixi Zhixin Bird Clean-care Product Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active Ingredient:

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose:

    Antiseptic

  • INDICATIONS & USAGE

    Uses:

    Kill germs while soothing skin. Contains Vintamin E and Aloe Vera

  • DOSAGE & ADMINISTRATION

    Directions:

    Aquirt as needed into your palms and thoroughly spread on both hands

  • 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 eys 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.

  • OTHER SAFETY INFORMATION

    Other Information:

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

  • INACTIVE INGREDIENT

    Inactive Ingredient:

    Deionized water, Vitamin E, Aloe vera, Glycerol, Boric acid, Carbomer, TX-20, Triethanolamine, White oil, Fragrance

  • PRINCIPAL DISPLAY PANEL

    label picture

  • INGREDIENTS AND APPEARANCE
    ULTRACRUZ ANTIBACTERIAL  NONE
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49877-011
    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) 96.105 g  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    ALOE (UNII: V5VD430YW9)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49877-011-01237 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(49877-011)
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