Label: REPARA TRIPLE ANTIBIOTIC- bacitracin, neomycin and polymyxin b ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 19, 2013

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  • 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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