Label: 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 December 9, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each gram)

    Neomycin Sulfate (3.5 mg Neomycin)

  • Purpose

    First Aid Antibiotic

  • Use

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

  • Warnings

    For external use only

    Do not use

    • in eyes
    • 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 you are allergic to any of the ingredients

    Stop use and ask a doctor if

    • a rash or allergic reaction develops
    • condition worsens or persists

    Keep out of reach of children

    If ingested, contact a Poison Control Center right away.

  • Directions

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

    mineral oil, petrolatum

  • Principal Display Panel - 0.03 oz Pouch Label

    BE SMART
    GET PREPARED    ®

    ANTIBIOTIC
    OINTMENT

    0.03 oz [0.90 g]

    SINGLE USE

    Mfd. for: Total Resources Intl.
    Walnut, California 91789
    00-OIN-21209 Rev.01 • NDC# 55550-730-21

    Principal Display Panel - 0.03 oz Pouch Label
  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC 
    neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55550-730
    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
    mineral oil (UNII: T5L8T28FGP)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55550-730-210.9 g in 1 POUCH; Type 0: Not a Combination Product10/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B10/07/2019
    Labeler - Total Resources International (790160535)
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