Label at a glance#

ProductAstonea First Aid

Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE

Label structure12 sections

Indications and uses

■ first aid to help prevent infection in ■ minor cuts ■ scrapes ■ burns

Dosage and administration

■ 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

Label contents#

Full prescribing information#

Active ingredients(in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)

Polymyxin B sulfate 5000 units

Purpose

OTC - PURPOSE SECTION

First Aid AntibioticFirst Aid AntibioticFirst Aid Antibiotic

Uses

INDICATIONS & USAGE SECTION

■ first aid to help prevent infection in ■ minor cuts ■ scrapes ■ burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

■ in the eyes ■ if you are allergic to any of the ingredients ■ over large areas of the body ■ longer than 1 week unless directed by a doctor

Ask a physician before use in case of

OTC - ASK DOCTOR SECTION

■ deep or puncture wounds ■ animal bites ■ serious burns

Stop use and consult a doctor if

OTC - STOP USE SECTION

■ the condition persists or gets worse ■ a rash or other allergic reaction develops

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 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

Other Information

SPL UNCLASSIFIED SECTION

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat and humidity■Tamper evident■Do not use if packet is cut, torn or opened

Inactive ingredients

INACTIVE INGREDIENT SECTION

white petrolatum

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
204602	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment	PSN	3
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	3
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 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
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
77338-302-53	2024-06-25	C162847	48780-1	1030e365-6b61-111a-e063-dadaa90a10e2	ASTONEA Triple Antibiotic
77338-302-54	2024-06-25	C162847	48780-1	1030e365-6b61-111a-e063-dadaa90a10e2	ASTONEA Triple Antibiotic
77338-302-53	2024-01-30	C162847	48780-1	1030e365-6b61-111a-e063-dadaa90a10e2	ASTONEA Triple Antibiotic
77338-302-54	2024-01-30	C162847	48780-1	1030e365-6b61-111a-e063-dadaa90a10e2	ASTONEA Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-302-53	AstoneaFirst Aid	0.9 g in 1 PACKET	OINTMENT	0.9		3
77338-302-54	AstoneaFirst Aid	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
77338-302	ASTONEA FIRST AID (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ASTONEA LABS PRIVATE LIMITED]	3	Legacy NDC, 2 package rows	20240627_de0982e3-37ab-a829-e053-2995a90a53e8.zip

Products#

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

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

Astonea First Aid
Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate
PETROLATUM
BACITRACIN ZINC
BACITRACIN
NEOMYCIN SULFATE
NEOMYCIN
POLYMYXIN B SULFATE
POLYMYXIN B

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77338-302	77338-302-53, 77338-302-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PETROLATUM	4T6H12BN9U	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
1bbad68f-2934-5848-e063-6394a90a448d			de0982e3-37ab-a829-e053-2995a90a53e8	2024-06-25	Warnings	Exact identifier spl id: 1bbad68f-2934-5848-e063-6394a90a448d spl set id: de0982e3-37ab-a829-e053-2995a90a53e8

Reported adverse events (FAERS/openFDA)#

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