Label: WOUND FIRST AID- bacitracin zinc 500 units ointment

  • Category: HUMAN OTC DRUG LABEL

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 March 17, 2021

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  • Active ingredient

    Bacitracin Zinc 500 units

  • Purpose

    Bacitracin Zinc 500 units........First aid antibiotic

  • Uses

    First aid to help prevent infection in

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week unless directed by doctor

    Ask a doctor before use if

    • on deep or puncture wounds, animal bites, or serious burns

    Stop use and ask doctor if

    • condition persists or gets worse
    • a 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 in a cool dry place away from light
  • Inactive ingredients

    allantoin, organic shea (butyrospermum parkii) butter, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, cetearyl olivate, organic coconut (cocos nucifera) oil, organic carnauba (copernicia cerifera) wax, organic eucalyptus
    (eucalyptus globulus) leaf oil, glycerin, hydrogenated castor oil, organic manuka (leptospermum scoparium) branch oil, magnesium sulfate, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, castor (ricinus communis) seed oil, organic rosemary (rosmarinus officinalis) leaf oil, sorbitan olivate, colloidal silver

  • Principal Display Panel

    HempFusion

    Wound

    OINTMENT

    First Aid Antibiotic

    Bacitracin Zinc USP

    BoxLabel

  • INGREDIENTS AND APPEARANCE
    WOUND FIRST AID 
    bacitracin zinc 500 units ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73672-982
    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
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MANUKA OIL (UNII: M6QU9ZUH2X)  
    BLACK PEPPER OIL (UNII: U17J84S19Z)  
    CLOVE OIL (UNII: 578389D6D0)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SILVER (UNII: 3M4G523W1G)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HEMP (UNII: TD1MUT01Q7)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73672-982-101 in 1 CARTON02/10/2020
    110 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B02/10/2020
    Labeler - HEMPFUSION, INC. (117152485)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc. (DBA Paklab) 177711082manufacture(73672-982)
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