Label: TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Bacitracin zinc 500 unitsFirst aid antibiotic
    Neomycin sulfate 3.5 mgFirst aid antibiotic
    Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
    Pramoxine HCl 10 mgExternal analgesic
  • Uses

    first aid to help prevent infection and for the temporary relief of pain in minor:

    • cuts
    • scrapes
    • 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
    • symptoms persist for more than 1 week, or clear up and occur again within a few days
    • rash or other allergic reaction develops

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

  • Directions

    • adults and children 2 years of age and older:
      • 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
    • children under 2 years of age: ask a doctor
  • Other information

    • store at 20° to 25°C (68° to 77°F)
    • to open: unscrew cap, pull tab to remove foil seal
    • see carton or tube crimp for lot number and expiration date
  • Inactive ingredient

    white petrolatum

  • Questions?

    Call toll free 1-877-994-3666Monday to Friday 8am to 6pm, Central time

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Genomma Lab USA Inc.
    Houston, TX 77098

  • PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

    cicatricure ®

    OPEN WOUND

    FOR MINOR CUTS, SCRAPES AND BURNS

    PAIN, ITCH & SCAR

    • Triple Antibiotic Ointment
    • Up to 24-Hour Infection Protection
    • Maximum Strength: Infection Protection,
      Pain & Itch Relief
    • Helps Healing Wounds, Minimizing
      the Appearance of Scars**

    FIRST AID ANTIBIOTIC
    PAIN RELIEVING OINTMENT

    Bacitracin Zinc – Neomycin Sulfate – Polyximin B Sulfate – Pramoxine HCl

    *Based on published studies. For best results use sterile bandage or gauze.
    **Preventing infection helps minimize appearance of scars.

    NET WT.
    1 oz (28.4 g)

    triple-antibiotic

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-202-011 in 1 CARTON12/21/2023
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00412/21/2023
    Labeler - GENOMMA LAB USA, INC. (832323534)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(50066-202)
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