Label: FIRST AID ONLY NEOMYCIN ANTIBIOTIC- neomycin sulfate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 May 4, 2023

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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, burns.

  • INDICATIONS & USAGE

    Use firstaid to help prevent infection in minor •scrapes •cuts •burns

  • Warnings:

    For external use only.

    Keep out of reach of children.

    If swallowed, contact a Poison Control Center right away

    Do Not Use:

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

    Stop use, ask a doctor if

    • a rash or allergic reaction develop
    • condition persists or gets worse
  • Directions

    • clean affected area
    • apply small amount 1 to 3 times daily
    • may cover with a sterile bandage
  • Inactive ingredients:

    mineral oil, petrolatum

  • Manufactured for:

    ©2021 Acme United Corporation

    1 Waterview Dr, Shelton, CT 06484

  • PRINCIPAL DISPLAY PANEL

    Pouch Label Pouch Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY NEOMYCIN ANTIBIOTIC 
    neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5620(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:0924-5620-000.9 g in 1 POUCH; Type 0: Not a Combination Product07/16/2021
    2NDC:0924-5620-0110 in 1 BOX05/10/2023
    20.9 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0924-5620-0220 in 1 BOX05/10/2023
    30.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/16/2021
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5620) , repack(0924-5620)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5620) , repack(0924-5620)
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