Label: NATUREPLEX ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate cream

  • Category: HUMAN OTC DRUG LABEL

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 September 30, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Bacitracin zinc 500 unitsFirst aid antibiotic
    Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
  • Use

    First aid to help prevent the risk of infection in minor cuts, scrapes, and burns

  • Warnings

    For external use only.

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

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

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • 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 up to 3 times daily
    • may be covered with a sterile bandage
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF FLAPS ON CARTON ARE NOT SEALED OR MISSING
  • Inactive ingredient

    petrolatum

  • Questions or comments?

    866-323-0107 or www.natureplex.com

  • PRINCIPAL DISPLAY PANEL - 14 g Tube Carton

    Natureplex™
    DUAL ANTIBIOTIC

    Antibiotic
    Ointment
    1
    2

    BACITRACIN ZINC • POLYMYXIN B SULFATE

    Dual Action
    First Aid

    NET WT 0.5 Oz (14g)

    PRINCIPAL DISPLAY PANEL - 14 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    NATUREPLEX ANTIBIOTIC 
    bacitracin zinc and polymyxin b sulfate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 U  in 14 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 U  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67234-077-011 in 1 CARTON09/28/2021
    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 finalpart333B09/28/2021
    Labeler - Natureplex LLC (062808196)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(67234-077)
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