Label: LINCOLN- bacitracin zinc 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 April 8, 2016

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  • Drug Facts

    Active Ingredient (in each gram)

    Bacitracin Zinc (equal to 500 bacitracin units)

  • Drug Facts

    First Aid Antibiotic

  • Drug Facts

    Uses

    • first aid to help prevent infection in minor
    • cuts scrapes
    • burns
  • Drug Facts

    For External use only

    Do not use

    • in the eyes
    • if you are allergenic to any of the ingredients
    • over large area of the body longer than 1 week unless directed by a doctor

    Drug Facts

    • deep or puncture wounds
    • animal bites
    • serious burns

    Drug Facts

    • the condition persists or get worse
    • a rash or other allergic reaction develops
  • Drug Facts

    Keep out of reach of children

    • if swallowed, get medical help or Contact a Poison Control Center right away
  • Drug Facts

    • clean the affected area
    • apply a small amount of this product (an amount equals 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
  • Drug Facts

    Other information:

    • store at controlled temperature 15°-30° C
    • Avoid excessive heat and humidity
  • Drug Facts

    Inactive ingredients

    hard paraffin, liquid paraffin, white soft paraffin, lanolin

  • Principal Display Panel

    principal display

  • INGREDIENTS AND APPEARANCE
    LINCOLN 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69636-3035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69636-3035-20.9 g in 1 PACKET; Type 0: Not a Combination Product05/30/2013
    2NDC:69636-3035-314 g in 1 TUBE; Type 0: Not a Combination Product05/30/2013
    3NDC:69636-3035-428 g in 1 TUBE; Type 0: Not a Combination Product05/30/2013
    4NDC:69636-3035-5113 g in 1 TUBE; Type 0: Not a Combination Product05/30/2013
    5NDC:69636-3035-6425 g in 1 JAR; Type 0: Not a Combination Product05/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/30/2013
    Labeler - Lincoln Pharmaceuticals Ltd. (915839373)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lincoln Pharmaceuticals Ltd915839373manufacture(69636-3035)
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