TRIPLE ANTIBIOTIC

Manufacturer
Shandong Teking Pharmaceutical Co., Ltd
Effective date
2022-10-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:51:11

Label at a glance#

ProductTRIPLE ANTIBIOTIC
Active ingredientPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN, LIDOCAINE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Polymyxin B sulfate 5000units

Neomycin sulfate 3500units

Bacitracin 500units

Lidocaine hydrochloride 40mg

OTC - PURPOSE SECTION

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

INDICATIONS & USAGE SECTION

First aid to help prevent infection and for the temporary relief of pain in minor:

  • cuts
  • scrapes
  • burns
  • surgical wound

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 - STOP USE SECTION

  • You need to use longer 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

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 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 2 to 4 times daily and 5 days as a course of treatment.

  • Children under 2 years of age: ask a doctor

OTHER SAFETY INFORMATION

  • Store at 10℃-30℃

INACTIVE INGREDIENT SECTION

Light mineral oil

White petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRIPLE ANTIBIOTIC OINTMENT

TRIPLE ANTIBIOTIC OINTMENT 1 oz (28.3g)TRIPLE ANTIBIOTIC OINTMENT 1 oz (28.3g)

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 OintmentPSN4
2281302bacitracin 0.5 UNT/MG / lidocaine hydrochloride 0.04 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD4
2281302bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical OintmentSY4

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
82695-0001-32024-01-30C16284748780-11030e365-373e-111a-e063-dadaa90a10e2dfa4ac4e-8ebd-fa0a-e053-2a95a90a4f63

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82695-0001-3TRIPLE ANTIBIOTIC28.3 g in 1 TUBEOINTMENT28.34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82695-0001TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN, LIDOCAINE HYDROCHLORIDE) OINTMENT [SHANDONG TEKING PHARMACEUTICAL CO., LTD]4Legacy NDC, 1 package rows20221027_dfa4ac4e-8ebd-fa0a-e053-2a95a90a4f63.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
82695-000182695-0001-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
ebd61edc-4a1d-2a36-e053-2a95a90af97fdfa4ac4e-8ebd-fa0a-e053-2a95a90a4f632022-10-25WarningsExact identifier
spl id: ebd61edc-4a1d-2a36-e053-2a95a90af97f
spl set id: dfa4ac4e-8ebd-fa0a-e053-2a95a90a4f63

Reported adverse events (FAERS/openFDA)#

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