Label: ADVANCED FIRST AID BACITRACIN- 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 October 18, 2016

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  • ACTIVE INGREDIENT

    Bacitracin Zinc 500 units

  • PURPOSE

    first aid antibiotic

  • INDICATIONS & USAGE

    Uses:

    First aid to help prevent infection in: • minor cuts • scrapes • burns

  • WARNINGS

    Warnings:

    • for external use only

  • DO NOT USE

    Do not use :

    • in the eyes

    • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock

    • over large areas of the body

    • longer than 1 week unless directed by a doctor

  • STOP USE

    Stop use and ask a doctor if:

    • before use in case of deep puncture wounds, animal bites or serious burns

    • if the condition persists or gets worse

    • if a rash or other allergic reaction develops

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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

  • OTHER SAFETY INFORMATION

    Other Information:

    • Tamper Evident. Do not use if packet is torn, cut or opened.

    • Avoid excessive heat and humidity

    • Store at a controlled room temperature 15° to 30°C (59° to 86°F)

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    white petrolatum

  • PRINCIPAL DISPLAY PANEL

    adv Bacitracin jar

  • PRINCIPAL DISPLAY PANEL

    adv Bacitracin Tube

  • PRINCIPAL DISPLAY PANEL

    advBacitracinPacket

  • PRINCIPAL DISPLAY PANEL

    advBAcitracinCarton

  • INGREDIENTS AND APPEARANCE
    ADVANCED FIRST AID BACITRACIN 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67060-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500   in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67060-400-53369 g in 1 JAR; Type 0: Not a Combination Product10/18/2016
    2NDC:67060-400-2828 g in 1 TUBE; Type 0: Not a Combination Product10/18/2016
    3NDC:67060-400-47144 in 1 CARTON10/18/2016
    3NDC:67060-400-090.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B10/18/2016
    Labeler - ADVANCED FIRST AID, INC. (114477180)
    Registrant - ADVANCED FIRST AID, INC. (114477180)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004pack(67060-400)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA TAB LABORATORIES, INC.151051757manufacture(67060-400)
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