Budpak Bacitracin Ointment

Manufacturer: Budpak Inc. | Anicare Pharmaceuticals Pvt. Ltd
Effective date: 2015-03-31
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:42:05

Label at a glance#

ProductBudpak Bacitracin

Active ingredientBACITRACIN ZINC

Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (each gram contains):

Bacitracin Zinc 500 units

OTC - PURPOSE SECTION

Purpose:

First aid antibiotic

INDICATIONS & USAGE SECTION

Uses:

First aid to help prevent infection in minor cuts, scrapes, and burns.

WARNINGS SECTION

Warnings:

For external use only.

OTC - DO NOT USE SECTION

Do not use:

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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use:

In case of deep or puncture wounds, animal bites or serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if:

Condition persists or gets worse. 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 immediately.

DOSAGE & ADMINISTRATION SECTION

Directions:

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.

SPL UNCLASSIFIED SECTION

Other Information:

Store at 15ºC to 25ºC (59ºF to 77ºF). Lot No. & Exp. Date: See box or crimp of tube.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Hard Paraffin, Liquid Paraffin, White Soft Paraffin .

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Budpak Bacitracin Ointment

First Aid Antibiotic with Zinc

NET WT .5 OZ (14 g)

carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1366116	bacitracin zinc 500 UNT/GM Topical Ointment	PSN	1
1366116	bacitracin zinc 0.5 UNT/MG Topical Ointment	SCD	1
1366116	bacitracin zinc 500 UNT per GM Topical Ointment	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BACITRACIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
27293-035-14	2020-01-31	C162847	48780-1	9d75b9d0-8770-f424-e053-dadaa90a57ce	Budpak Bacitracin Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
27293-035-14	Budpak Bacitracin	14 g in 1 TUBE	OINTMENT	14		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27293-035	BUDPAK BACITRACIN (BACITRACIN ZINC) OINTMENT [BUDPAK INC.]	1	Legacy NDC, 1 package rows	20150331_82f6a0de-2c20-4db2-9434-6f12ad6ee718.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	1
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

Budpak Bacitracin
Bacitracin Zinc
MINERAL OIL
PARAFFIN
BACITRACIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
27293-035	27293-035-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	IACT
PARAFFIN	I9O0E3H2ZE	IACT
BACITRACIN ZINC	89Y4M234ES	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 1 · 41 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / RECTAL		38 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SUSPENSION / TOPICAL		11726 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SOAP / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, DELAYED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	AEROSOL, FOAM / TOPICAL		14235 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	CAPSULE, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, COATED / ORAL	0.07 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, EXTENDED RELEASE / ORAL		321 mg	Exact identifier — unii candidate 11 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
1299b298-f18b-392e-e054-00144ff8d46c			82f6a0de-2c20-4db2-9434-6f12ad6ee718	2015-03-31	Warnings	Exact identifier spl id: 1299b298-f18b-392e-e054-00144ff8d46c spl set id: 82f6a0de-2c20-4db2-9434-6f12ad6ee718

Reported adverse events (FAERS/openFDA)#

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