Label: 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 July 12, 2023

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  • Active Ingredient

    Bacitracin Zinc 500 Units per gram

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

    In care of deep puncture wounds, animal bites, or serious burns.

  • Stop Use and Ask Doctor if

    • The condition persists or gets worse
    • A rash or allergic reaction develops
  • 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
  • Inactive Ingredients

    Aloe barbadensis leaf juice, mineral oil, petrolatum

  • Questions

    Call 1-800-645-2158

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Other Information

    Store Between 15° to 25°C (59° to 77°F)

    Lot No. and Expiration Date: See box and tube crimp

    Distributed By:

    RUGBY LABORATORIES

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

    www.rugbylaboratories.com

    1-800-645-2158

    Made in China

  • Packaging

    370817 RUGBY BACITRACIN ZINC OINTMENT 1OZ 090621 CDER

  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1263
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1263-281 in 1 BOX04/15/2020
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/15/2020
    Labeler - Rugby Laboratories (079246066)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
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