BACITRACIN ZINC OINTMENT [SION BIOTEXT MEDICAL LTD]

BACITRACIN ZINC OINTMENT [SION BIOTEXT MEDICAL LTD]
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NDC 68786-220-01, 68786-220-02, 68786-220-03, 68786-220-04, 68786-220-05, 68786-220-06, 68786-220-07
Set ID 120f363b-c9d1-467d-b8d4-82c2023800eb
Category HUMAN OTC DRUG LABEL
Packager Sion Biotext Medical Ltd
Generic Name
Product Class
Product Number
Application Number PART333B
  • Active Ingredient

    Active ingredient                                            Purpose

    Bacitracin Zinc (equal to 500 Bacitracin units)                 Antibiotic

  • Uses:

    First aid to help prevent infection in:

    • Minor cuts
    • scrapes
    • burns
  • Ask a doctor before use:

    • in case of deep or puncture wounds
    • animal bites
    • serious burns

  • Other information

    • store at controlled room temperature 15°-30° C (59°-86° F)
    • Avoid excessive heat and humidity
    • tamper evident. Do not use if packet is torn, cut or open.
  • Inactive ingredients

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • Directions

    • clean the affected area
    • apply a small amount of this product ( an equal amount to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • Stop use and ask a doctor if:

    • the condition persists or gets worse
    • a rash or other allergic reaction develops
  • Keep Out Of Reach Of Children

    • Keep Out Of Reach Of Children
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Indications and Usage

    • First aid to help prevent infections
    • Not for ophthalmic use
  • Warnings

    • FOR EXTERNAL USE ONLY
    • Not for ophthalmic use.
  • PRINCIPAL DISPLAY PANEL

    Sion Biotext Medical Ltd

    Bacitracin Zinc Ointment

    SBM Bacitracin Zinc.jpg

    Label

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68786-220-0272 in 1 CASE07/06/2012
    128.35 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68786-220-0112 in 1 CASE07/06/2012
    2144 in 1 BOX
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:68786-220-0372 in 1 CASE07/06/2012
    314.2 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:68786-220-0472 in 1 CASE07/06/2012
    4113.4 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:68786-220-0512 in 1 CASE07/06/2012
    5144 in 1 BOX
    50.5 g in 1 PACKET; Type 0: Not a Combination Product
    6NDC:68786-220-0672 in 1 CASE07/06/2012
    656.8 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:68786-220-0712 in 1 CASE07/06/2012
    7426 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/06/2012
    Labeler - Sion Biotext Medical Ltd (532775194)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture(68786-220)

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