Soundbody Triple Antibiotic Ointment

Manufacturer: Kareway Product, Inc.
Effective date: 2023-01-27
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:53:32

Label at a glance#

ProductTriple Antibiotic

Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE

Label structure8 sections

Indications and uses

First aid to help prevent infection in minor: cuts scrapes burns

Dosage and administration

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

Storage and handling

store at 15° to 25°C (59° to 77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Purpose

OTC - PURPOSE SECTION

First 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

If you are allergic to any of the ingredients

When using this product

OTC - WHEN USING SECTION

do not use in the eyes
do not apply over large areas of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

you need to use longer than 1 week
condition persists or gets worse
rash or other allergic reaction develops

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

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

Other information

STORAGE AND HANDLING SECTION

store at 15° to 25°C (59° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, mineral oil, petrolatum, squalane, stearic acid, tocopheryl acetate

Package label panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment

carton

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	5
204602	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment	SCD	5
204602	bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment	SY	5

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
67510-0631-1	2025-01-30	C162847	48780-1	ab0e2407-2a2e-f274-e053-dbdaa90a6471	Soundbody Triple Antibiotic Ointment
67510-0631-1	2020-10-09	C162847	48780-1	ab0e2407-2a2e-f274-e053-dbdaa90a6471	Soundbody Triple Antibiotic Ointment
67510-0631-1	2020-09-27	C162847	48780-1	ab0e2407-2a2e-f274-e053-dbdaa90a6471	Soundbody Triple Antibiotic Ointment
67510-0631-1	2020-09-25	C162847	48780-1	ab0e2407-2a2e-f274-e053-dbdaa90a6471	Soundbody Triple Antibiotic Ointment
67510-0631-1	2020-07-22	C162847	48780-1	ab0e2407-2a2e-f274-e053-dbdaa90a6471	Soundbody Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67510-0631-1	Triple Antibiotic	28.3 g in 1 TUBE	OINTMENT	28.3		5
67510-0631-1	Triple Antibiotic	1 in 1 BOX	OINTMENT	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67510-0631	TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [KAREWAY PRODUCT, INC.]	5	Legacy NDC, 2 package rows	20230129_b249ea8c-5418-4189-a39b-ce0174fa60c6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	1
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	1
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	1
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	1
STEARETH-2	INACTIVE INGREDIENT	V56DFE46J5	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

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

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

Triple Antibiotic
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B
CETYL ALCOHOL
MINERAL OIL
SQUALANE
STEARIC ACID
.ALPHA.-TOCOPHEROL ACETATE
PETROLATUM
BACITRACIN ZINC
BACITRACIN
NEOMYCIN SULFATE
NEOMYCIN
POLYMYXIN B SULFATE
POLYMYXIN B

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67510-0631	67510-0631-1

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
CETYL ALCOHOL	936JST6JCN	IACT
MINERAL OIL	T5L8T28FGP	IACT
SQUALANE	GW89575KF9	IACT
STEARIC ACID	4ELV7Z65AP	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
PETROLATUM	4T6H12BN9U	IACT
BACITRACIN ZINC	89Y4M234ES	ACTIM
NEOMYCIN SULFATE	057Y626693	ACTIM
POLYMYXIN B SULFATE	19371312D4	ACTIM

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 167 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / TOPICAL		82 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	TABLET, FILM COATED / ORAL	2.49 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
STEARETH-2	STEARETH-2	V56DFE46J5	OINTMENT / TOPICAL		714 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	PASTILLE / ORAL	3.6 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
STEARETH-2	STEARETH-2	V56DFE46J5	LOTION / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	EMULSION / TOPICAL		68100 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	LOTION / TOPICAL		48000 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SQUALANE	SQUALANE	GW89575KF9	POWDER / ORAL	0.02 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	TABLET / ORAL	7.5 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, ORALLY DISINTEGRATING / ORAL		9 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	SYSTEM / TRANSDERMAL		170 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	GEL / TOPICAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / VAGINAL	4 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates

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
f344a0a6-5099-27b3-e053-2995a90a6c43			b249ea8c-5418-4189-a39b-ce0174fa60c6	2023-01-27	Warnings	Exact identifier spl id: f344a0a6-5099-27b3-e053-2995a90a6c43 spl set id: b249ea8c-5418-4189-a39b-ce0174fa60c6

Reported adverse events (FAERS/openFDA)#

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