Label: POMADA SULFA FIRST AID 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 January 6, 2022

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  • ACTIVE INGREDIENT

    Neomycin Sulfate 0.5%

  • PURPOSE

    FIRST AID ANTIBIOTIC

  • INDICATIONS

    First aid to help prevent infection in minor

    • cuts
    • scrapes
    • burns
  • WARNINGS

    For external use only. Do not use in the eyes or over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor. Stop use and consult a doctor if condition persists or gets worse. Do not use longer than one week unless directed by a doctor. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Store at room temperature.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

  • DIRECTIONS

    • Clean the affected area.
    • Apply a small amount of the product (an amount equal to surface area of the tip of a finger) on the area 1 to 3 times daily.
    • May be covered with a single bandage.
  • INACTIVE INGREDIENTS

    PETROLATUM 99.5%

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Sulfa Edit - 01_DF

    01b LBL_Sulfa Edit - 01_DF2

  • INGREDIENTS AND APPEARANCE
    POMADA SULFA FIRST AID ANTIBIOTIC 
    neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48201-103(NDC:52137-2924)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48201-103-1140 g in 1 JAR; Type 0: Not a Combination Product02/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/06/2020
    Labeler - Grandall Distributing Co., Inc. (044428324)