FDA.reportPublic FDA data

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

Key Label Information#

Active Ingredients And Purpose

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

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection and for the temporary relief of pain in minor: cuts scrapes burns surgical wound

Warnings

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

Directions And Dosage

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 Label Information

INACTIVE INGREDIENT SECTION

Light mineral oil White petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRIPLE ANTIBIOTIC OINTMENT

Label Images#

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#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82695-000182695-0001-3

Ingredients#

Name, UNII, Kind table
NameUNIIKind
POLYMYXIN B SULFATE19371312D4ACTIM
NEOMYCIN SULFATE057Y626693ACTIB
BACITRACIN58H6RWO52IACTIB
LIDOCAINE98PI200987ACTIB
LIGHT MINERAL OILN6K5787QVPIACT
WHITE PETROLATUMB6E5W8RQJ4IACT

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Polymyxin B sulfate 5000units Neomycin sulfate 3500units Bacitracin 500units Lidocaine hydrochloride 40mg

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

First aid antibiotic First aid antibiotic First aid antibiotic External analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Deep or puncture wounds Animal bites Serious burns

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Store at 10℃-30℃

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

Light mineral oil White petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRIPLE ANTIBIOTIC OINTMENT

Source Document#

Source XML