FIRST AID ONLY ANTIBIOTIC NEOMYCIN SULFATE (ANTIBIOTIC OINTMENT) OINTMENT [ACME UNITED CORPORATION]

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FIRST AID ONLY ANTIBIOTIC NEOMYCIN SULFATE (ANTIBIOTIC OINTMENT) OINTMENT [ACME UNITED CORPORATION]
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NDC 0924-5607-01, 0924-5607-02, 0924-5607-03, 0924-5607-05
Set ID 60a1dbf8-c3b8-105f-e053-2991aa0aa5c7
Category HUMAN OTC DRUG LABEL
Packager Acme United Corporation
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
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  • Active Ingredient (Each gram contains)

    Neomycin sulfate (equivalent to 3.5 mg Neomycin base)

  • Purpose

    First aid antibiotic

  • Uses

    first aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use

    • in the eyes or apply 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 if you have

    • 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 out of the reach of children

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

  • 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 59° to 77°F (15°to 25°C)
  • Inactive ingredients

    Petrolatum

  • Questions or comments?

    800-835-2263

  • Principal Display Panel

    Carton Image

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY ANTIBIOTIC  NEOMYCIN SULFATE
    antibiotic ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5607(NDC:59898-730)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5607-03144 in 1 CARTON12/18/2017
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-5607-0210 in 1 CARTON12/18/2017
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-5607-0520 in 1 CARTON12/18/2017
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-5607-010.9 g in 1 PACKET; Type 0: Not a Combination Product04/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/18/2017
    Labeler - Acme United Corporation (001180207)
    Registrant - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5607) , repack(0924-5607)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corpoation080119599relabel(0924-5607) , repack(0924-5607)
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