CAREALL Bacitracin

Manufacturer: New World Imports, Inc
Effective date: 2025-12-02
Label type: HUMAN OTC DRUG LABEL
Version: 14
Source: full-release
Hydrated at: 2026-06-01 01:19:33

Label at a glance#

ProductCAREALL Bacitracin

Active ingredientBACITRACIN ZINC

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc

OTC - PURPOSE SECTION

First Aid Antibiotic

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.

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor:

cuts
scrapes
burns

WARNINGS SECTION

For external use only

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

Ask a doctor before use if you have:

animal bites
serious burns
deep or puncture wounds

Stop use and ask a doctor if

condition persists or gets worse
rash or other allergic reaction develops

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 the finger) on the area 1 to 3 times daily
may be covered with a sterile bandage

INACTIVE INGREDIENT SECTION

Mineral Oil, Paraffin, White Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bacitracin label

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0085317005207	GTIN-13: 0085317005207 EAN-13: 0085317005207 GTIN-12: 085317005207 UPC-A: 085317005207 GTIN storage (14 digits): 00085317005207	Bacitracin Label.jpg

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51824-003-01	CAREALL Bacitracin	28 g in 1 TUBE	CREAM	28	14
51824-003-09	CAREALL Bacitracin	0.9 g in 1 PACKET	CREAM	0.9	14
51824-003-14	CAREALL Bacitracin	144 in 1 CARTON	CREAM	144	14
51824-003-25	CAREALL Bacitracin	25 in 1 CARTON	CREAM	25	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51824-003-01	GM - Gram	51824-003	c8c68dd7-7db2-4357-8a9f-647f6ab81f8c	1	2020-03-10
51824-003-09	EA - Each	51824-003	1af31d01-0f5c-4b89-9c1c-8d880b1c4080	1	2024-08-12
51824-003-14	EA - Each	51824-003	82bc5025-de54-4f90-83a6-8c24f06ec3ee	1	2024-08-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Bacitracin Zinc	ACTIVE INGREDIENT	89Y4M234ES	5
Bacitracin Zinc	ACTIVE MOIETY	89Y4M234ES	5
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	5
Paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	5
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	5

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

CAREALL Bacitracin
Bacitracin Zinc
PARAFFIN
MINERAL OIL
WHITE PETROLATUM
BACITRACIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51824-003	51824-003-01, 51824-003-09, 51824-003-25, 51824-003-14

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
PARAFFIN	I9O0E3H2ZE	IACT
MINERAL OIL	T5L8T28FGP	IACT
WHITE PETROLATUM	B6E5W8RQJ4	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 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
Paraffin	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL	300 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL	2772 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL	4213 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL	300 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL	4213 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL	300 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL	2772 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL	300 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Paraffin	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL	300 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL	2772 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL	2772 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL	4213 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL	4213 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL	4213 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL	2772 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N000004-004	PAREDRINE	HYDROXYAMPHETAMINE HYDROBROMIDE	1%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N000004-004	PAREDRINE	1%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`f41ea6bd6efb…`

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
CAREALL Bacitracin	BACITRACIN ZINC	New World Imports, Inc	ea16e1de-0100-456b-abe6-d33de78221da	2025-12-02	Warnings	Exact identifier ndc (package): 51824-003-14 ndc (package): 51824-003-25 ndc (package): 51824-003-09 ndc (package): 51824-003-01 ndc (product): 51824-003 ndc11 (package): 51824000301 ndc11 (package): 51824000325 ndc11 (package): 51824000309 ndc11 (package): 51824000314 spl id: 4500451e-fef7-66b4-e063-6294a90a8ecc spl set id: ea16e1de-0100-456b-abe6-d33de78221da

Reported adverse events (FAERS/openFDA)#

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