Label: LUCKY SUPERSOFT FIRST AID- bacitracin neomycin polymyxin b ointment

  • 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 November 22, 2022

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  • Active ingredients

    Bacitracin 400 units

    Neomycin 3.5 mg

    Polymyxin B 5000 units

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

  • Use

    first aid to help prevent infection 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 ■ serious burns ■ animal bites 

  • Stop use and consult a doctor if

    ■ you need to use longer than 1 week ■ condition persists or gets worse ■ 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

    ■ 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 information

    ■ store at room temperature 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

  • Inactive ingredients

    cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPERSOFT  FIRST AID
    bacitracin neomycin polymyxin b ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-175
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COTTONSEED OIL (UNII: H3E878020N)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47046-175-0114 g in 1 TUBE; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/31/2015
    Labeler - Anicare Pharmaceuticals pvt. Ltd. (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals916837425manufacture(47046-175)
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