81552-004 Triple Antibiotic Ointment

Manufacturer: ROOSIN MEDICAL CO., LTD
Effective date: 2021-04-24
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:39:56

Label at a glance#

ProductRoosin Triple Antibiotic

Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE

Label structure7 sections

Dosage and administration

Clean affected area Apply small amount 1 to 3 times daily May be covered with a sterile bandage

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 0.048%

Neomycin Sulfate 1%

Polymyxin B Sulfate 0.6%

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

Use

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

In the eyes
Over large areas of the body
If you are allergic to any of the ingredients
Longer than 1 week unless directed by a doctor

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 affected area

Apply small amount 1 to 3 times daily

May be covered with a sterile bandage

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2539801	bacitracin zinc 0.048 % / neomycin sulfate 1 % / polymyxin B sulfate 0.6 % Topical Ointment	PSN	1
2539801	bacitracin zinc 0.00048 MG/MG / neomycin sulfate 0.01 MG/MG / polymyxin B sulfate 0.006 MG/MG Topical Ointment	SCD	1
2539801	bacitracin zinc 0.048 % / neomycin sulfate 1 % / polymyxin B sulfate 0.6 % Topical Ointment	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BACITRACIN 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
81552-005-01	2023-01-30	C162847	48780-1	f386c64a-27e1-0266-e053-dadaa90a7c1a	81552-004 Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81552-005-01	Roosin Triple Antibiotic	0.5 g in 1 TUBE	OINTMENT	0.5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81552-005	ROOSIN TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [ROOSIN MEDICAL CO., LTD]	1	Legacy NDC, 1 package rows	20210425_c0ba21e8-6782-689c-e053-2a95a90a4db4.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Roosin Triple Antibiotic
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
PETROLATUM
PARAFFIN
OCTADECANOL (MIXTURE OF ISOMERS)
WATER
STEARIC ACID
GLYCEROL FORMAL
BACITRACIN ZINC
BACITRACIN
NEOMYCIN SULFATE
NEOMYCIN
POLYMYXIN B SULFATE
POLYMYXIN B

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
81552-005	81552-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PETROLATUM	4T6H12BN9U	IACT
PARAFFIN	I9O0E3H2ZE	IACT
OCTADECANOL (MIXTURE OF ISOMERS)	C6BPY2QY39	IACT
WATER	059QF0KO0R	IACT
STEARIC ACID	4ELV7Z65AP	IACT
GLYCEROL FORMAL	3L7GR2604E	IACT
BACITRACIN ZINC	89Y4M234ES	ACTIM
NEOMYCIN SULFATE	057Y626693	ACTIM
POLYMYXIN B SULFATE	19371312D4	ACTIM

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
c0ba21d5-ca5c-5af2-e053-2a95a90a14f8			c0ba21e8-6782-689c-e053-2a95a90a4db4	2021-04-24	Warnings	Exact identifier spl id: c0ba21d5-ca5c-5af2-e053-2a95a90a14f8 spl set id: c0ba21e8-6782-689c-e053-2a95a90a4db4

Reported adverse events (FAERS/openFDA)#

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