Label: FAMILY WELLNESS PAIN SCAR ITCH- bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointment

  • NDC Code(s): 69396-054-01
  • Packager: Trifecta Pharmaceutical USA LLC
  • 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 January 17, 2023

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  • DRUG FACTS

  • Active Ingredient

    Bacitracin 500 Units

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Neomycin 3.5mg

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Polymyxin B 10,000 Units

  • Purpose

    First Aid Antibiotic

  • Active Ingredient

    Pramoxine HCL 10mg

  • Purpose

    Pain Reliever

  • Uses

    Helps prevent infection in and temporarily relieves pain due to minor cuts, scrapes and burns.

  • Warnings

    For external use only. Do not use:

    • If you are allergic to any of the ingredients
    • in or near the eyes
    • on large areas of the body

  • Ask a Doctor before Use

    Ask Doctor before use if you have:

    • Deep or puncture wouns
    • Animal bites
    • Serious burns
  • Stop Use and ask a Doctor if:

    • Condition persists or gets worse
    • Symptoms last for more than 7 days or clear up and come back within a few days
    • A rash or other allergic reaction develops
  • When using this product

    Do not use longer than 1 week

  • 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 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: ask a doctor

  • Other Information

    • To Open: Unscrew cap, pull tab to remove foil seal
    • Store at 20° to 25°C (68° to 77°F)
    • See carton or tube crimp for lot number and expiration date
  • Inactive Ingredient:

    Cocoa Butter, Levant Cottonseed Oil, Olive Oil, Petrolatum, Sodium pyruvate, vitamin E

  • Questions?

    Call 1-888-296-9067 Weekdays 9AM - 4PM EST

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC.

    500 Volvo Parkway, Chesapeake, VA. 23320

    NOT SATISFIED?

    Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

    This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin® Plus Pain Relief.

  • Packaging

    69396-054-01 fd pain scar itch SKU 999855 2.11.20

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS PAIN SCAR ITCH 
    bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-054
    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
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-054-011 in 1 BOX09/22/2019
    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 finalpart333B08/30/2019
    Labeler - Trifecta Pharmaceutical USA LLC (079424163)
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