CALLINGTON ANTI-BACTERIAL HAND SANITISER (BENZALKONIUM CHLORIDE) CLOTH [JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.]

CALLINGTON ANTI-BACTERIAL HAND SANITISER (BENZALKONIUM CHLORIDE) CLOTH [JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.]
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NDC 71734-210-01
Set ID 1c6650c9-29fa-4fba-8442-fe294a2087c0
Category HUMAN OTC DRUG LABEL
Packager JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART333A
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    BENZALKONIUM CHLORIDE  ..........  0.05%

  • Purpose

    Antiseptic

  • Uses:

    Antiseptic cleansing of hands to decrease bacteria on skin without the use of soap and water.

  • WARNINGS

    For external use only.

    • for external use only.
    • do not use in eyes. If this occurs, rinse thoroughly with water.
    • Stop use and ask a doctor if irritation o redness develops and 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.

  • Directions

    Tear open packedt, unfold and use as wash cloth. Allow hands to dry without wiping.

  • Inactive Ingredients:

    Water, Propylene glycol, Polysorbate 20, Dipropylene glycol, Ethylhexylglycerin, Chlorphenesin, Bronopol, Citric acid.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    CALLINGTON ANTI-BACTERIAL HAND SANITISER 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71734-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Water (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71734-210-014.2 g in 1 PACKAGE; Type 0: Not a Combination Product02/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/04/2018
    Labeler - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Registrant - JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. (544530534)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.544530534MANUFACTURE(71734-210)

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