Label: BACIGUENT- bacitracin ointment

  • NDC Code(s): 69784-880-01, 69784-880-35
  • Packager: Woodward Pharma Services LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated August 26, 2020

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  • STERILE Rx Only

  • DESCRIPTION:

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

  • CLINICAL PHARMACOLOGY:

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

  • INDICATIONS AND USAGE:

    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:

    Baciguent® 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.

    To report SUSPECTED ADVERSE REACTIONS, contact Woodward Pharma Services LLC at 1-844-200-7910 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • 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:

    NDC 69784-880-01 3 – 1 g sterile tamper evident tubes with ophthalmic tip.

    NDC 69784-880-35 3.5 g (1/8 oz.) sterile tamper evident tubes with ophthalmic tip.

    Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

  • SPL UNCLASSIFIED SECTION

    Manufactured For
    Woodward Pharma Services LLC
    Wixom, MI 48393

    Rev 11-19
    5G000 CJ J1

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Label

    Rx Only

    NDC 69784-880-35

    Baciguent®
    (Bacitracin Ophthalmic Ointment, USP)

    STERILE

    NET WT 3.5 g (1/8 oz)

    USUAL DOSAGE: Apply 1 to 3 times daily. See package insert for full prescribing information.

    Each gram contains: 500 units of bacitracin in a base of white petrolatum and mineral oil.

    KEEP TIGHTLY CLOSED

    Store at 20° to 25°C (68°-77°F) [see USP Controlled Room Temperature].

    KEEP OUT OF REACH OF CHILDREN

    Bacitracin Ophthalmic Ointment 1 g Label
  • INGREDIENTS AND APPEARANCE
    BACIGUENT 
    bacitracin ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69784-880
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69784-880-013 in 1 CARTON04/15/2020
    11 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69784-880-351 in 1 CARTON04/15/2020
    23.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06121204/15/2020
    Labeler - Woodward Pharma Services LLC (026749066)
    Registrant - Woodward Pharma Services LLC (026749066)