Label: FAMILY CARE 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 29, 2017

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  • ACTIVE INGREDIENT

    Active ingredient (in each gram) Purpose

    Neomycin sulfate 3.5 mg...................................................................First Aid-Antibiotic

  • WARNINGS

    Warnings

    For external use only

  • PURPOSE

    Uses

    first aid to help prevent infection in:

    • minor cuts
    • scrapes
    • burns

  • DO NOT USE

    Do not use

    • in the eyes
    • if you are allergic to any of the ingredients
    • over large areas of the body
    • longer than 1 week unless directed by a doctor
  • ASK DOCTOR

    Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

  • STOP USE

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • rash or other allergic reaction develops
    • the condition persists or gets worse
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    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
  • STORAGE AND HANDLING

    Other information

    • ​store between 20° to 25°C (68° to 77°F)
    • Lot No. & Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    cetanol, ethanol, liquid paraffin, methylparaben, petrolatum, propylparaben, purified lanolin, squalane, tocopherol acetate

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

    www.ueccorp.com

    1 800 814 8028

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    513

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE ANTIBIOTIC 
    neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-517
    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
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LANOLIN (UNII: 7EV65EAW6H)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-517-281 in 1 BOX12/29/2017
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/29/2017
    Labeler - United Exchange Corp. (840130579)
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