Triple Antibiotic

Manufacturer: Shandong Ruian Pharmaceutical Co.,Ltd.
Effective date: 2021-11-13
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:44:59

Label at a glance#

ProductTriple Antibiotic

Active ingredientPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN, LIDOCAINE

Label structure11 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

For external use only.

INACTIVE INGREDIENT SECTION

white petrolatum

OTC - DO NOT USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

First aid antibiotic
External analgesic

OTC - ASK DOCTOR SECTION

• deep or puncture wounds
• animal bites
• serious burns

OTC - ACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

store at 10-30°C

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 the area 1 to 3 times daily
• may be covered with a sterile bandage
• children under 2 years of age: ask a doctor

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:82199-530-12 28.3 g in 1 TUBE

28.3 g label

NDC:82199-530-11 14.2 g in 1 TUBE

14.2g label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2281302	bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical Ointment	PSN	3
2281302	bacitracin 0.5 UNT/MG / lidocaine hydrochloride 0.04 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	3
2281302	bacitracin 500 UNT / lidocaine HCl 40 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical Ointment	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BACITRACIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
NEOMYCIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
POLYMYXIN B Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82199-530-11	2023-01-30	C162847	48780-1	f386c649-e696-0266-e053-dadaa90a7c1a	cae7322c-17de-0d81-e053-2a95a90a08d7
82199-530-12	2023-01-30	C162847	48780-1	f386c649-e696-0266-e053-dadaa90a7c1a	cae7322c-17de-0d81-e053-2a95a90a08d7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82199-530-11	Triple Antibiotic	14.2 g in 1 TUBE	OINTMENT	14.2		3
82199-530-12	Triple Antibiotic	28.3 g in 1 TUBE	OINTMENT	28.3		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82199-530	TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE,NEOMYCIN SULFATE,BACITRACIN) OINTMENT [SHANDONG RUIAN PHARMACEUTICAL CO.,LTD.]	3	Legacy NDC, 2 package rows	20211120_cae7322c-17de-0d81-e053-2a95a90a08d7.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Triple Antibiotic
Polymyxin B sulfate,Neomycin sulfate,Bacitracin
POLYMYXIN B SULFATE
POLYMYXIN B
NEOMYCIN SULFATE
NEOMYCIN
BACITRACIN
PETROLATUM
LIDOCAINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82199-530	82199-530-11, 82199-530-12

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
POLYMYXIN B SULFATE	19371312D4	ACTIM
NEOMYCIN SULFATE	057Y626693	ACTIB
BACITRACIN	58H6RWO52I	ACTIB
PETROLATUM	4T6H12BN9U	IACT
LIDOCAINE	98PI200987	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d0a66c43-7e18-d47f-e053-2995a90a1f05			cae7322c-17de-0d81-e053-2a95a90a08d7	2021-11-13	Warnings	Exact identifier spl id: d0a66c43-7e18-d47f-e053-2995a90a1f05 spl set id: cae7322c-17de-0d81-e053-2a95a90a08d7

Reported adverse events (FAERS/openFDA)#

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