BACITRACIN OINTMENT [DYNAREX CORPORATION]

BACITRACIN OINTMENT [DYNAREX CORPORATION]
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NDC 67777-219-01, 67777-219-02, 67777-219-03, 67777-219-04, 67777-219-05, 67777-219-06, 67777-219-07
Set ID e8e4f5e5-0506-4a68-b9b7-19c48b9ae053
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART333
  • ACTIVE INGREDIENT

    Active ingredient               Purpose
    Bacitracin 500 Units                Antibiotic

  • Warnings:

    For external use only

    Dosage and Administration:

    • clean the affected areas
    • apply a small amount of product (an amount equal to the surface area of the tip of the 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, or if a rash or other allergic reaction develops.

    Do not use:

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

    Keep out of reach of children

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

  • Purpose

    First aid to help prevent infection in:
    Minor cuts
    scrapes
    burns

  • Indications and Usage

    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)
  • Inactive ingredients

    Light Mineral Oil, White Petrolatum

  • Principal Display Panel

    Bacitracin Ointment:

    bacitracin-galentic-ointment-01.jpg

    1162_1163_Bacitracin_Ointment

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-219-0172 in 1 CASE
    128.35 g in 1 TUBE
    2NDC:67777-219-0472 in 1 CASE
    214.17 g in 1 TUBE
    3NDC:67777-219-0612 in 1 CASE
    3144 in 1 BOX
    30.5 g in 1 PACKET
    4NDC:67777-219-0712 in 1 CASE
    4144 in 1 BOX
    40.9 g in 1 PACKET
    5NDC:67777-219-0572 in 1 CASE
    556.7 g in 1 TUBE
    6NDC:67777-219-0272 in 1 CASE
    6113.4 g in 1 TUBE
    7NDC:67777-219-0312 in 1 CASE
    7425.3 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/01/2009
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)

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