REPARA TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN AND POLYMYXIN B) OINTMENT [PSS WORLD MEDICAL, INC.]

REPARA TRIPLE ANTIBIOTIC (BACITRACIN, NEOMYCIN AND POLYMYXIN B) OINTMENT [PSS WORLD MEDICAL, INC.]
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NDC 68345-820-22, 68345-820-26
Set ID f169f613-91b3-47f2-aac1-49cd1d7f6d8a
Category HUMAN OTC DRUG LABEL
Packager PSS WORLD MEDICAL, INC.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • Active Igredients:

    Bacitracin 400 units

    Neomycin 3.5 mg

    Polymyxin B 5,000 units

  • Purpose:

    Antibiotic


  • Inactive Ingredients:

    White petrolatum

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses:

    First aid antibiotic to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • Warnings:

    FOR EXTERNAL USE ONLY.

    Do not use

    • in the eyes or apply over large areas of the body

    • if you are allergic to any of the ingredients

    Ask a doctor before use if you have

    • deep or puncture wounds, animal bites or serious burns

    Stop use and ask a doctor if

    • the condition worsen

    • symptons last more than 7 days or clear up and occur again within a few days

  • Directions:

    • clean the affected area
    • apply a small amount of the product (an amount equal 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
  • Comments or Questions?

    800-777-4908

    Manufactured for PSS World Medical, Inc.
    4345 Southpoint Blvd., Jacksonville, FL 32216
    Made in China

  • Storage Information

    Store at temperature between 15°C - 30°C (59°F- 86°F).

  • Package Label

    Repara® Advanced Skincare

    NDC 68345-820-26

    Triple Antibiotic Ointment Bacitracin•Neomycin•Polymyxin B

    NET WT. 28g. Reorder #892

    892_Each

    892_Each

    892_EachBox

    892_EachBox

    892_Box

    892_Box

    892_Case

    892_Case

  • INGREDIENTS AND APPEARANCE
    REPARA TRIPLE ANTIBIOTIC 
    bacitracin, neomycin and polymyxin b ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-820
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68345-820-2212 in 1 CASE
    1144 in 1 BOX
    10.9 g in 1 POUCH
    2NDC:68345-820-2612 in 1 CASE
    212 in 1 BOX
    228 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/01/2007
    Labeler - PSS WORLD MEDICAL, INC. (101822682)
    Registrant - Zhejiang Medicare Pharmaceutical Co., Ltd. (421293835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Medicare Pharmaceutical Co., Ltd.421293835manufacture(68345-820)

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