TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]

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  • TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]

TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]
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NDC 61010-5600-1, 61010-5600-2, 61010-5600-3
Set ID 96c41fc1-81f9-4757-abc6-867b5383ed5d
Category HUMAN OTC DRUG LABEL
Packager Safetec of America, Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each gram)

    Bacitracin Zinc (400 units Bacitracin)

    Neomycin Sulfate (3.5 mg Neomycin)

    Polymyxin B Sulfate (Polymyxin B 5000 units)

  • Purposes

    First Aid Antibiotic

    First Aid Antibiotic

    First Aid Antibiotic

  • Uses

    First aid to help prevent infection in minor cuts, scrapes and burns

  • Warnings

    For external use only

    Do not use:

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

    Ask a doctor before use:

    • in case of deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if:

    • the condition persists or gets worse
    • a rash or other allergic reaction develops

    Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

  • Directions

    • Clean the affected area
    • Apply a small amount of this 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
  • Other Information

    • Store at room temperature (do not freeze)
    • Do Not Use any Opened or Torn Packets
  • Inactive Ingredient

    White Petrolatum

  • Questions or Comments?

    1-800-456-7077

  • PRINCIPAL DISPLAY PANEL – pouch

    Safetec

    Triple Antibiotic
    Ointment

    0.9 g (1/32 oz.)

    Safetec of America, Inc.
    Buffalo, NY 14215
    800-456-7077

    PRINCIPAL DISPLAY PANEL – pouch
  • PRINCIPAL DISPLAY PANEL – 144 count box

    NDC 61010-5600-2

    Safetec

    First Aid
    Triple Antibiotic Ointment

    First Aid to Help Prevent
    Infection in Minor Cuts,
    Scrapes, and Burns

    Reorder no. 53210
    To reorder:
    Call: 1-800-456-7077
    Fax: 716-895-2969
    Online: www.safetec.com

    PRINCIPAL DISPLAY PANEL – 144 count box
  • Principal Display Panel – 10 Packet Box Label

    Safetec®

    First Aid
    Triple Antibiotic
    Ointment

    Helps prevent infection in minor
    cuts, scrapes, and burns

    10 Packets

    Each Packet Net. Wt. 0.9g

    Made in USA

    Reorder No. 53208

    Principal Display Panel – 10 Packet Box Label
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC  
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I) bacitracin400 [USP'U]  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 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-5600-10.9 g in 1 POUCH; Type 0: Not a Combination Product08/08/2011
    2NDC:61010-5600-2144 in 1 BOX08/08/2011
    20.9 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:61010-5600-325 in 1 BOX08/08/2011
    30.9 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:61010-5600-410 in 1 BOX04/01/2020
    40.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/08/2011
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(61010-5600)
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