Label: SINGLE ANTIBIOTIC WITH NEOMYCIN- neomycin sulfate ointment

  • NDC Code(s): 61010-6700-1, 61010-6700-2, 61010-6700-3
  • Packager: Safetec of America
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each gram)

    Neomycin Sulfate (3.5 mg Neomycin)

  • Purpose

    First Aid Antibiotic

  • Uses:

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

  • Warnings:

    For external use only.

    Keep out of reach of children.

    If ingested, get medical help or contact a Poison Control Center directly.

    Do Not Use:

    • in the eyes or over large areas of the body, or on puncture wounds, animal bites or serious burns
    • for more than 1 week unless directed by a doctor
    • if allergic to any of the ingredients

    Stop use, ask a doctor if:

    • condition persists or gets worse
    • a rash or allergic reaction develops
  • Directions:

    • clean affected area
    • apply a small amount of this product (equal to the surface area of the tip of finger) 1 to 3 times daily
    • may cover with a sterile bandage
  • Inactive ingredients:

    mineral oil, petrolatum

  • Questions or Comments? 1-800-456-7077

  • Principal Display Panel - Box Label

    NDC 61010-6700-2

    Safetec

    First Aid

    Single Antibiotic Ointment

    • with Neomycin
    • First Aid to Help Prevent
      Infection In Minor Cuts,
      Scrapes, and Burns

    Reorder No. 53610

    To reorder:

    Call: 1-800-456-7077

    Fax: 716-895-2969

    Online: www.safetec.com

    Principal Display Panel - Box Label
  • Principal Display Panel - Pouch Label

    Safetec

    Single Antibiotic
    Ointment

    (Neomycin)

    0.9 g (1/32 oz.)

    Safetec of America, Inc.

    Buffalo, NY 14215

    800-456-7077

    Principal Display Panel - Pouch Label
  • Principal Display Panel - Box Label

    NDC 61010-6700-3

    Safetec

    First Aid

    Single Antibiotic Ointment

    • with Neomycin
    • First Aid to Help Prevent
      Infection In Minor Cuts,
      Scrapes, and Burns

    25 Packets

    Each Packet Net. Wt. 0.9gm

    Principal Display Panel - Box Label
  • Principal Display Panel - Pouch Label

    Safetec

    Single Antibiotic
    Ointment

    (Neomycin)

    0.9 g (1/32 oz.)

    Safetec of America, Inc.

    Buffalo, NY 14215

    800-456-7077

    Principal Display Panel - Pouch Label
  • INGREDIENTS AND APPEARANCE
    SINGLE ANTIBIOTIC WITH NEOMYCIN 
    neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-6700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-6700-2144 in 1 BOX11/13/2008
    1NDC:61010-6700-10.9 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:61010-6700-325 in 1 BOX11/13/2008
    2NDC:61010-6700-10.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00411/13/2008
    Labeler - Safetec of America (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-6700)