ZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]

ZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]
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NDC 59428-135-14
Set ID c8704895-8819-49ac-8baa-5b97be1d00aa
Category HUMAN OTC DRUG LABEL
Packager Zapatol Corp.
Generic Name
Product Class
Product Number
Application Number PART333B
  • ACTIVE INGREDIENT

    Active ingredient (each gram contains)                                      Purpose

    Bacitracin 500 units.....................................................................First Aid Antibiotic

  • PURPOSE

    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
    • overlarge areas of the body
    • if you are allergic to any of the ingredients
    • 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

    • the condition persists or gets worse
    • 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.

  • 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
  • OTHER SAFETY INFORMATION

    Other Information

    • Store at 15°C to 25°C (59°F to 77°F)
    • Lot NO., & Exp. Date: see box or see crimp to tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera gel, light mineral oil and white petrolatum

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    Productos Zapotol Corp.

    Van Nuys, CA 91402 888-927-6865

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ZAPOTOL BACITRACIN 
    bacitracin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59428-135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59428-135-141 in 1 PACKAGE10/13/2016
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/06/2014
    Labeler - Zapatol Corp. (186063850)

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