Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

  • NDC Code(s): 68016-319-01
  • Packager: Premier Value Alliance LLC.
  • 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 May 9, 2023

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

View All Sections
  • Active ingredients (each gram contains)

    Bacitracin zinc 400 units

    Neomycin sulfate 3.5 mg

    Polymyxin B sulfate 5,000 units

  • Purpose

    First aid antibiotic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Uses   first aid to help prevent infection in minor:● cuts ● scrapes ● burns

  • WARNINGS

    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.

    Ask a doctor before use if you have

    ● deep or puncture wounds ● animal bites ● serious burns.

    Stop use and ask a doctor if ● condition persists or gets worse

    ● you need to use longer than 1 week

    ● a rash or other allergic reaction develops

  • INACTIVE INGREDIENT

    Inactive ingredient:Cetyl Alcohol, Light Mineral Oil, Squalane, Stearic Acid, Vitamin E and Petrolatum

  • Other information

    ● To open: unscrew cap, pull tab to remove foil seal

    ● store at 20° to 25°C ( 68° to 77°F)

    ● see carton or tube for lot number and expiration date.

  • QUESTIONS

    Questions? Call 1-866-923-4914

  • Other Information

    Distributed By:

    Pharmacy Value Alliance, LLC.

    407 East Lancaster Avenue, Wayne, PA. 19087

    Product of PRC

    If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

  • Directions

    Clean the affected area and dry thoroughly.

    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.

  • Packaging

    pv triple antibiotic 1oz PV03642

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-319
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SQUALANE (UNII: GW89575KF9)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-319-011 in 1 BOX01/10/2019
    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 finalpart333B01/10/2019
    Labeler - Premier Value Alliance LLC. (101668460)
    Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!