BACITRACIN OINTMENT [SION BIOTEXT MEDICAL LTD]

BACITRACIN OINTMENT [SION BIOTEXT MEDICAL LTD]
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NDC 68786-218-01, 68786-218-02, 68786-218-03, 68786-218-04, 68786-218-05, 68786-218-06, 68786-218-07
Set ID 600d6533-027c-4f2f-960e-93c59d14cf97
Category HUMAN OTC DRUG LABEL
Packager Sion Biotext Medical Ltd
Generic Name
Product Class
Product Number
Application Number PART333B
  • Active Ingredient

    Active ingredient               Purpose

    Bacitracin 500 Units                Antibiotic

  • Uses:

    First aid to help prevent infection in:

    • Minor cuts
    • scrapes
    • burns
  • Warnings:

    • FOR EXTERNAL USE ONLY
    • Do not use in the eyes, if you are allergic to any of the ingredients, over large areas of the body, longer than 1 week unless directed by a doctor
    • 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

  • Indications and Usage

    • clean the affected areas
    • apply a small amount (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

    Stop use and ask a doctor if:

    • if condition persist or gets worse
    • a rash or other allergic reaction develops
  • Keep Out Of Reach Of Children

    Keep Out Of Reach Of Children

    • If swallowed get medical help or contact a Poison Control Center right away.
  • Dosage and Administration


    • Do not use over large areas of the body, longer than 1 week unless directed by a doctor
    • apply a small amount (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
  • Principal Display Panel

    NDC 68786-218-01/02/03/04/05/06/07

    BACITRACIN OINTMENT

    FIRST AID ANTIBIOTIC

    NET WT 1 oz. (28.4 g)

    Label

  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-218
    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:68786-218-0112 in 1 CASE07/09/2012
    1144 in 1 BOX
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:68786-218-0372 in 1 CASE07/09/2012
    214.17 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:68786-218-0472 in 1 CASE07/09/2012
    328.35 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:68786-218-0212 in 1 CASE07/09/2012
    4144 in 1 BOX
    40.5 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:68786-218-0572 in 1 CASE07/09/2012
    556.8 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:68786-218-0672 in 1 CASE07/09/2012
    6113.6 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:68786-218-0712 in 1 CASE07/09/2012
    7426 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/09/2012
    Labeler - Sion Biotext Medical Ltd (532775194)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sion Biotext Medical Ltd532775194manufacture(68786-218)

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