Label: TRIPLE ANTIBIOTIC WITH PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment

  • NDC Code(s): 61010-4401-1
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each gram)

    Bacitracin Zinc (500 units)

    Neomycin Sulfate 5mg (3.5mg Neomycin)

    Polymyxin B Sulfate (5000 units)

    Pramoxine Hydrochloride (10mg)

  • Purpose

    First Aid Antibiotic

    First Aid Antibiotic

    First Aid Antibiotic

    Pain Reliever

  • Uses

    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 if you havedeep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if

    • The 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 (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 at room temperature

  • Inactive Ingredients

    White Petrolatum

  • Principal Display Panel - 1 oz. Tube Label

    Safetec®

    Triple Antibiotic Ointment
    with Pain Relief

    Net Wt. 1 oz. (28.4g)

    Reorder No. 53206

    Manufactured for: Safetec of America, Inc.
    Buffalo, NY 14215 | 1-800-456-7077

    Made in IndiaKD/503

    Principal Display Panel - 1 oz. Tube Label
  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIBIOTIC WITH PAIN RELIEF 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-4401-128.4 g in 1 TUBE; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00411/01/2019
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262manufacture(61010-4401)
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!