OB TOWELETTE (BENZALKONIUM CHLORIDE) SOLUTION [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]

OB TOWELETTE (BENZALKONIUM CHLORIDE) SOLUTION [H AND P INDUSTRIES, INC. DBA TRIAD GROUP]
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NDC 50730-5102-0
Set ID 60a3aa8b-d16b-4368-8fab-d613c4e7ee5a
Category HUMAN OTC DRUG LABEL
Packager H and P Industries, Inc. dba Triad Group
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT

    Benzalkonium chloride .4%
  • PURPOSE

    Antiseptic

  • USE

    Antiseptic to help prevent the risk of infection
  • WARNINGS

    For external use only.

    Do not

    • use in the eyes
    • use as a first aid antiseptic longer than one week
    • apply over large areas of the body

    Ask a doctor in case of

    • deep or puncture wounds
    • animal bites
    • serious burns



    Stop use and ask a doctor

    if condition persists or gets worse



    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • clean the affected area
    • apply a small amount of this product to the area 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • SPL UNCLASSIFIED SECTION


  • STORAGE AND HANDLING


  • INACTIVE INGREDIENTS

    fragrance, o-phenylphenol, sodium bicarbonate, water
  • QUESTIONS


  • CARTON INFORMATION

    TRIAD

    Cat. No. 10-5102
    NDC 50730-5102-0

    Obstetrical Antiseptic Towelettes

    Helps prevent the risk of skin infections
    For Professional and Hospital Use Only

    100 towelettes

    carton






  • INGREDIENTS AND APPEARANCE
    OB TOWELETTE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-5102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzalkonium chloride (UNII: F5UM2KM3W7) (benzalkonium - UNII:7N6JUD5X6Y) benzalkonium chloride.004 mL
    Inactive Ingredients
    Ingredient NameStrength
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-5102-0100 in 1 CARTON
    11 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/1999
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture

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