FDA.reportPublic FDA data

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate Ointment

Manufacturer
Proficient Rx LP
Effective date
2021-04-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:46:09

Label at a glance#

ProductTRIPLE ANTIBIOTIC
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure13 sections

Indications and uses

Helps prevent infection in • minor cuts • scrapes • burns

Dosage and administration

• clean affected area • apply a small 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 • Store at controlled room temperature 59º - 86ºF (15º - 30ºC). • Protect from freezing.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

(in each gram)

Bacitracin zinc, USP 400 units

Neomycin sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 5,000 units

PURPOSE

OTC - PURPOSE SECTION

First aid antibiotic

USES

INDICATIONS & USAGE SECTION

Helps prevent infection in

  • minor cuts
  • scrapes
  • burns

WARNINGS

WARNINGS SECTION

For external  use only

Allergy alert:

  • do not use if allergic to any of the ingredients

DO NOT USE

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • do not use longer than 1 week unless directed by a doctor

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

  • condition persists or gets worse
  • a rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • clean affected area
  • apply a small 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

SPL UNCLASSIFIED SECTION

  • Store at controlled room temperature 59º - 86ºF (15º - 30ºC).
  • Protect from freezing.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

White petrolatum

QUESTIONS?

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63187-039-01

Triple Antibiotic Ointment

FIRST AID ANTIBIOTIC

(Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate Ointment)

First Aid to Help Prevent Infection in Minor Cuts, Scrapes and Burns

Compare to the active ingredients in Neosporin®*

NET WT 1 OZ (28 g)

*This product is not affiliated with, manufactured by, or produced by the makers of Neosporin®.

  1. 01791210G1 VC110203

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Made in India

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

63187-039-15
63187-039-15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-039-01GM - Gram63187-0396e600ee6-c2d2-4e37-acd7-ae6acd16b18c12017-06-15
63187-039-15GM - Gram63187-039f85fc1c4-7ca0-4edf-9381-e850c94da2cc12016-04-04
0472-0179-34GM - Gram0472-0179f4ba8432-cf28-4d7e-86d8-ad3eaf115bdd12012-07-24
0472-0179-56GM - Gram0472-017902c98cec-6f68-468d-bf85-8c881eb854a212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y6266931
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D41
BACITRACINACTIVE MOIETY58H6RWO52I1
NEOMYCINACTIVE MOIETYI16QD7X2971
POLYMYXIN BACTIVE MOIETYJ2VZ07J96K1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63187-03963187-039-15, 63187-039-01
0472-0179

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
75a8b67a-fe09-40a6-b6e7-3eb1c821960f45b1c4da-11ac-4e3a-8c77-0b0cdb78df242024-10-01WarningsExact identifier
spl set id: 45b1c4da-11ac-4e3a-8c77-0b0cdb78df24

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.