Label: LUCKY SUPERSOFT FIRST AID- bacitracin zinc 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 Ingredient (in each gram)

    Bacitracin zinc 500 units

  • Purpose

    First aid antibiotic

  • Uses

    helps prevent infection in: ■ minor cuts ■ scrapes ■ burns

  • Warnings

    For external use only

    Alergy alert

    ■ do not use if allergic to any of the ingredients

  • Do not use

    ■ in eyes ■ on large areas of the body

  • Ask a doctor before use if you have

    ■ deep or puncture wounds ■ animal bites ■ serious burns

    When using this product ■ do not use longer than 1 week

  • When using this product

    ■ do not use longer than 1 week

  • Stop use and ask a doctor if

    ■ condition lasts 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 15-25C (59-77F) 

    ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

  • Inactive ingredients

    white petrolatum

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPERSOFT   FIRST AID
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47046-174
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47046-174-0114 g in 1 TUBE; Type 0: Not a Combination Product03/01/2015
    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 Pharmaceuticals Pvt. Ltd.916837425manufacture(47046-174)
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