Label: ZAPOTOL BACITRACIN- bacitracin cream

  • 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 11, 2021

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  • 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
    • over large areas of the body
    • if you are allergic to any of the ingredients
  • ASK DOCTOR

    Ask a doctor before useif

    • you need to use longer than 1 week
    • condition persists or gets worse
    • rash or other allergic reaction develops
  • STOP USE

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • a rash or other allergic reaction develops

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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
  • STORAGE AND HANDLING

    Other Information

    • Store at 20°C to 25°C (68°F to 77°F)
    • keep carton for future reference
    • tamper evident: do not use if carton or foil under cap is broker or missing
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera leaf extract, ethyl alcohol, light mineral oil, methylparaben, petrolatum, stearyl alcohol

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    Productos Zapotol Corp.

    Palmdate, CA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    1350A

  • 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 LEAF (UNII: ZY81Z83H0X)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALCOHOL (UNII: 3K9958V90M)  
    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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