Label: CAREALL BACITRACIN- bacitracin zinc cream

  • NDC Code(s): 51824-003-01, 51824-003-09, 51824-003-14, 51824-003-25
  • Packager: New World Imports, Inc
  • 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 January 5, 2022

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

  • ACTIVE INGREDIENT

    Bacitracin Zinc

  • PURPOSE

    First Aid Antibiotic

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

     First aid to help prevent infection in minor cuts, scrapes, and 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


  • DOSAGE & ADMINISTRATION

    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

  • INACTIVE INGREDIENT

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CAREALL BACITRACIN 
    bacitracin zinc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-003
    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
    Paraffin (UNII: I9O0E3H2ZE)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-003-0128 g in 1 TUBE; Type 0: Not a Combination Product06/01/2012
    2NDC:51824-003-2525 in 1 CARTON05/01/2022
    2NDC:51824-003-09.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:51824-003-14144 in 1 CARTON05/01/2022
    3NDC:51824-003-09.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/01/2012
    Labeler - New World Imports, Inc (075372276)