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 5, 2013

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  • Active ingredient (in each gram)

    Neomycin 3.5mg

  • Purposes

    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
    • over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than one week unless directed by a doctor

    Consult a doctor in case of

    deep or puncture woundsanimal bitesserious burns

    Stop use and ask a doctor if

    the condition persists or gets worsea rash or other allergic reaction occurs

    Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    adults and children 2 years of age and older:

    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finer) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age:  ask a doctor
  • Other information

    • store at room temperature
  • Inactive ingredients

    Cetyl alcohol, Light Mineral Oil, Methylparaben, Propylparaben, Squalane, Tocopheryl acetate, White petrolatum

  • Package label

    Antibiotic Ointment

    image of caton label

  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC 
    neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0038
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SQUALANE (UNII: GW89575KF9)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58988-0038-11 in 1 BOX
    128.35 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/05/2013
    Labeler - Promex, LLC (789974388)
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