LUCKY SUPERSOFT FIRST AID (BACITRACIN NEOMYCIN POLYMYXIN B) OINTMENT [DELTA BRANDS, INC]

LUCKY SUPERSOFT FIRST AID (BACITRACIN NEOMYCIN POLYMYXIN B) OINTMENT [DELTA BRANDS, INC]
PDF | XML

NDC 20276-103-14
Set ID bb3f660e-cbae-44e2-b1cb-4afdbb778b52
Category HUMAN OTC DRUG LABEL
Packager Delta Brands, Inc
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • 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:20276-103
    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:20276-103-1414 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 - Delta Brands, Inc (102672008)
    Establishment
    NameAddressID/FEIBusiness Operations
    anicare pharmaceuticals pvt.ltd916837425manufacture(20276-103)

Related Drugs