Label: BACITRACIN ZINC ointment

  • NDC Code(s): 50382-006-11, 50382-006-12, 50382-006-13, 50382-006-16, view more
    50382-006-20
  • Packager: Galentic Pharma (India) Private Limited
  • 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 26, 2019

If you are a consumer or patient please visit this version.

  • • ACTIVE INGREDIENT

    • Active Ingredient (each gram contains)
      Bacitracin Zinc 500 units
  • • PURPOSE

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

    • Ask a doctor before use

    in case of deep or puncture wounds, animal bites, or serious burns

    • Stop use and ask a doctor if

    • 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 immediately.

  • • DIRECTIONS

    • Clean the affected area
    • Apply a small amount of this product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
    • May be covered with a sterile bandage
  • • OTHER INFORMATION

    • Store at 15° to 30°C (59° to 86°F)
    • Lot No. & Exp. Date. See box or crimp of tube.
  • • INACTIVE INGREDIENT

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • SPL UNCLASSIFIED SECTION

    Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,

    Gandhidham-370 230, Gujarat. India

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Galentic

    Bacitracin
    Ointment
    FIRST AID ANTIBIOTIC

    BACITRACIN
    ZINC

    Helps to Heal Burns, Scrapes & Cuts
    Prevents Infections

    NET WT.
    1 OZ. (28g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-006-11144 in 1 CARTON08/07/2017
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50382-006-121 in 1 CARTON08/07/2013
    214.2 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:50382-006-131 in 1 CARTON08/07/2013
    328 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:50382-006-161 in 1 CARTON08/07/2013
    4113 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:50382-006-2012 in 1 CASE08/07/2017
    5425 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/07/2013
    Labeler - Galentic Pharma (India) Private Limited (915110464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Private Limited650970176analysis(50382-006) , manufacture(50382-006) , pack(50382-006) , repack(50382-006) , sterilize(50382-006)