FDA.reportPublic FDA data

Triple Antibiotic

Manufacturer
Morales Distributors Inc.
Effective date
2012-10-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:33:11

Label at a glance#

ProductTriple Antibiotic
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure11 sections

Indications and uses

First aid to help prevent infection in minor: cuts scrapes burns

Dosage and administration

adults and children 2 years of age and older: 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 children under 2 years of age: ask a doctor

Storage and handling

store at 59 degrees to 77 degrees Fahrenheit

Label contents#

Full prescribing information#

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Purposes

OTC - PURPOSE SECTION

First aid antibiotic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Do not use if you are allergic to any of the ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • serious burns
  • deep or puncture wounds
  • animal bites

When using this product

OTC - WHEN USING SECTION

  • do not use in the eyes
  • do not apply over large areas of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you need to use more than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week or clear up and occur again within a few days
  • 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

  • adults and children 2 years of age and older:
    • 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
  • children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 59 degrees to 77 degrees Fahrenheit

Inactive ingredients

INACTIVE INGREDIENT SECTION

Liquid paraffin, Cethanol, Squalane, Lanolin, Petrolatum, Tocopheryl acetate

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC NO. 53210-1004-0

First Aid Prevent Infection

Cuts Scrapes Burns

Maximum Strength

Help Prevent Infection in Minor Cuts, Scrapes and Burns

Soothing Ointment

Original
TRIPLE ANTIBIOTIC
Polymyxin B Sulfate-Bacitracin Zinc-Neomycin Sulfate

Net 1 oz(28.3g)

Exclusively distributed by:
Morales Distributors, Inc
Mayaguez, P.R. 00682

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Original Neosporin (R)

Made in Korea

carton label 1
carton label 1

carton label 2
carton label 2

tube label
tube label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN5
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD5
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53210-1004-02019-11-27C16284748780-19855d018-db14-cd31-e053-dbdaa90ab51aTriple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53210-1004-0Triple Antibiotic1 in 1 BOXOINTMENT15
53210-1004-0Triple Antibiotic28 g in 1 TUBEOINTMENT285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53210-1004TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [MORALES DISTRIBUTORS INC.]5Legacy NDC, 2 package rows20121002_c3f80241-58ec-4608-8807-482ba8c91eef.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ES5
NEOMYCIN SULFATEACTIVE INGREDIENT057Y6266935
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D45
BACITRACINACTIVE MOIETY58H6RWO52I5
NEOMYCINACTIVE MOIETYI16QD7X2975
POLYMYXIN BACTIVE MOIETYJ2VZ07J96K5
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L05
LANOLININACTIVE INGREDIENT7EV65EAW6H5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U5
SQUALANEINACTIVE INGREDIENTGW89575KF95

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53210-100453210-1004-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
MINERAL OILT5L8T28FGPIACT
SQUALANEGW89575KF9IACT
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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 2 · 65 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 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
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9CREAM / TOPICAL6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9POWDER / ORAL0.02 mgExact identifier — unii candidate
5 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii candidate
5 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSPRAY / NASALNAExact identifier — unii candidate
9 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / VAGINAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / OPHTHALMIC59.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 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
3173a08b-5f96-4c1e-8668-9c34360fb55fc3f80241-58ec-4608-8807-482ba8c91eef2012-10-01WarningsExact identifier
spl id: 3173a08b-5f96-4c1e-8668-9c34360fb55f
spl set id: c3f80241-58ec-4608-8807-482ba8c91eef

Reported adverse events (FAERS/openFDA)#

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