Triple Antibiotic

Manufacturer
Shandong Ruian Pharmaceutical Co.,Ltd.
Effective date
2021-11-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:00

Label at a glance#

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

POLYMYXIN B SULFATE;
NEOMYCIN SULFATE;
BACITRACIN ZINC;
LIDOCAINE HYDROCHLORIDE

OTC - PURPOSE SECTION

First aid antibiotic
External analgesic

INDICATIONS & USAGE SECTION

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:
• cuts
• scrapes
• burns

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body

OTC - ASK DOCTOR SECTION

• deep or puncture wounds
• animal bites
• serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• adults and children 2 years of age or 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 thearea 1 to 3 times daily
• may be covered with a sterile bandage
• children under 2 years of age: ask a doctor

OTHER SAFETY INFORMATION

store at 10°C-30°C

INACTIVE INGREDIENT SECTION

petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82199-531-13 14.2 g in 1 TUBE

14.2g label14.2g label

NDC: 82199-531-14 28.3 g in 1 TUBE

28.3g label28.3g label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2281302bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical OintmentPSN1
2281302bacitracin 0.5 UNT/MG / lidocaine hydrochloride 0.04 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD1
2281302bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE 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
82199-531-132023-01-30C16284748780-1f386c649-bd88-0266-e053-dadaa90a7c1ad11d53d1-f960-dfe9-e053-2995a90aa681
82199-531-142023-01-30C16284748780-1f386c649-bd88-0266-e053-dadaa90a7c1ad11d53d1-f960-dfe9-e053-2995a90aa681

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82199-531-13Triple Antibiotic14.2 g in 1 TUBEOINTMENT14.21
82199-531-14Triple Antibiotic28.3 g in 1 TUBEOINTMENT28.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82199-531TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE,NEOMYCIN SULFATE,BACITRACIN ZINC,LIDOCAINE HYDROCHLORIDE) OINTMENT [SHANDONG RUIAN PHARMACEUTICAL CO.,LTD.]1Legacy NDC, 2 package rows20211120_d11d53d1-f960-dfe9-e053-2995a90aa681.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82199-53182199-531-13, 82199-531-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
d11d53d1-f961-dfe9-e053-2995a90aa681d11d53d1-f960-dfe9-e053-2995a90aa6812021-11-18WarningsExact identifier
spl id: d11d53d1-f961-dfe9-e053-2995a90aa681
spl set id: d11d53d1-f960-dfe9-e053-2995a90aa681

Reported adverse events (FAERS/openFDA)#

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