Label: FIRST AID ONLY ANTIBIOTIC NEOMYCIN SULFATE- antibiotic ointment ointment

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 4, 2019

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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

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  • 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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