FDA.reportPublic FDA data

Triple Antibiotic Ointment

Manufacturer
SOLA Pharmaceuticals
Effective date
2022-07-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:50:04

Label at a glance#

ProductTriple Antibiotic
Active ingredientNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC
Label structure12 sections

Indications and uses

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

Dosage and administration

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 the doctor

Label contents#

Full prescribing information#

Active Ingerdients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc USP 400 Units

Neomycin Sulfate USP 5mg (equivalent to 3.5mg of Neomycin)

Polymixin B Sulfate USP 5,000 Units

Purpose

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

OTC - DO NOT USE SECTION

Do not use:

  • If you are allergic to any of the ingredients
  • In the eyes
  • Over large areas of the body

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Stop use and ask a doctor if:

  • You need to use longer than 1 week
  • Condition persists or gets worse
  • Rash or other allergic reaction developes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 the doctor

Other Information

OTHER SAFETY INFORMATION

  • Store at 20-25°C (68-77°F)
  • Store away from heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

White Petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-866-747-7365

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured for : SOLA Pharmaceuticals

Baton Rouge, LA 70810

Triple Antibiotic


NDC 70512-102-30


Qty: 28.4g

TripleTriple

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 OintmentPSN4
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD4
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY4

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
70512-102-302024-01-30C16284748780-11030e365-29a6-111a-e063-dadaa90a10e2Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-102-30Triple Antibiotic1 in 1 CARTONOINTMENT14
70512-102-30Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70512-102TRIPLE ANTIBIOTIC OINTMENT [SOLA PHARMACEUTICALS]4Legacy NDC, 2 package rows20220706_bb2a2488-602f-c5c3-e053-2995a90a058e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-102-30GM - Gram70512-1028cae5f34-08b0-484b-8da1-6847ec248af012021-06-02

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70512-10270512-102-30

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
NEOMYCIN SULFATE057Y626693ACTIB
POLYMYXIN B SULFATE19371312D4ACTIM
WHITE PETROLATUMB6E5W8RQJ4IACT
BACITRACIN ZINC89Y4M234ESACTIM

Source Document#

Source XML

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
e314cc52-3f74-9a9c-e053-2a95a90a3f4abb2a2488-602f-c5c3-e053-2995a90a058e2022-07-05WarningsExact identifier
spl id: e314cc52-3f74-9a9c-e053-2a95a90a3f4a
spl set id: bb2a2488-602f-c5c3-e053-2995a90a058e

Reported adverse events (FAERS/openFDA)#

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