BACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]

BACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]
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NDC 42254-003-35
Set ID a3dc310a-3d75-4e1e-9f9f-ed5c77ff7bfe
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Rebel Distributors Corp
Generic Name
Product Class
Product Number
Application Number ANDA061212
  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION:

    Each gram of ointment contains 500 units of Bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.

  • ACTION:

    The antibiotic, Bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphylococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi.

  • INDICATIONS:

    For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by Bacitracin susceptible organisms.

  • CONTRAINDICATIONS:

    This product should not be used in patients with a history of hypersensitivity to Bacitracin.

  • PRECAUTIONS:

    Bacitracin ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted.

  • ADVERSE REACTIONS:

    Bacitracin has such a low incidence of allergenicity that for all practical purposes side reactions are practically non-existent. However, if such reaction should occur, therapy should be discontinued.

  • DOSAGE AND ADMINISTRATION:

    The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.

  • HOW SUPPLIED:

    3.5 g (1/8 Oz) sterile tamper proof tubes, NDC 42254-003-35.

  • SPL UNCLASSIFIED SECTION

    Fera logo

    Manufactured for:

    Fera Pharmaceuticals, LLC
    Locust Valley, NY 11560

    FPBC00N                   Rev. 08/09

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320

  • PRINCIPAL DISPLAY PANEL

    Bacitracin 500 Units

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42254-003(NDC:48102-007)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42254-003-351 in 1 CARTON
    13.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06121201/11/2010
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK

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