FULL CARE BZK TOWELETTE (BENZALKONIUM CHLORIDE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]

FULL CARE BZK TOWELETTE (BENZALKONIUM CHLORIDE) SOLUTION [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]
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NDC 65028-002-01
Set ID ce3f2d21-f7ba-46d2-87c2-f7257de151eb
Category HUMAN OTC DRUG LABEL
Packager Shaoxing Fuqing Health Products Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT

    Active Ingredient: Benzalkonium Chloride (0.13%)

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    Use: Antiseptic cleasing of face, hands, and body without soap and water. Air dries in seconds.

  • WARNINGS

    Warnings:

    For external use only

    Avoid contact with eyes. If contact occurs, flush eyes with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or consult a poison control center right away

  • ASK DOCTOR

    Stop use if irritation, redness, or other syptoms develop.

    Consult a doctor if condition persists or gets worse.

  • DOSAGE & ADMINISTRATION

    Directions:

    Tear open packet, unfold towelette and use to cleanse desired skin area. Discard toweletted appropriately after single use.

  • INACTIVE INGREDIENT

    Inactive Ingredient

    Purified water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FULL CARE BZK TOWELETTE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65028-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0026 g  in 2 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65028-002-012 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/22/2014
    Labeler - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
    Registrant - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shaoxing Fuqing Health Products Co., Ltd.530545003manufacture(65028-002)

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