CLOBETASOL PROPIONATE

Manufacturer: Aleor Dermaceuticals Limited | Encube Ethicals Pvt. Ltd.
Effective date: 2019-08-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 00:17:31

Label at a glance#

ProductCLOBETASOL PROPIONATE

Active ingredientCLOBETASOL PROPIONATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71589-002-15

Aleor Dermaceuticals Ltd.

Clobetasol Propionate Ointment USP, 0.05%

Rx only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE.

NET WT 15 grams

NDC 71589-002-15

Aleor Dermaceuticals Ltd.

Clobetasol Propionate Ointment USP, 0.05%

Rx only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE.

NET WT 15 grams

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71589-002-15	2025-02-27	C162847	48780-1	1030e365-0689-111a-e063-dadaa90a10e2	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-30	2025-02-27	C162847	48780-1	1030e365-0689-111a-e063-dadaa90a10e2	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-45	2025-02-27	C162847	48780-1	1030e365-0689-111a-e063-dadaa90a10e2	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-60	2025-02-27	C162847	48780-1	1030e365-0689-111a-e063-dadaa90a10e2	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-15	2024-01-30	C162847	48780-1	1030e365-0689-111a-e063-dadaa90a10e2	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-30	2024-01-30	C162847	48780-1	1030e365-0689-111a-e063-dadaa90a10e2	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-45	2024-01-30	C162847	48780-1	1030e365-0689-111a-e063-dadaa90a10e2	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
71589-002-60	2024-01-30	C162847	48780-1	1030e365-0689-111a-e063-dadaa90a10e2	Clobetasol Propionate Ointment USP, 0.05% (Potency expressed as clobetasol propionate) Rx Only FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

Products#

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

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

CLOBETASOL PROPIONATE
CLOBETASOL
PROPYLENE GLYCOL
SORBITAN SESQUIOLEATE
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71589-002	71589-002-15, 71589-002-30, 71589-002-45, 71589-002-60

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
CLOBETASOL PROPIONATE	779619577M	ACTIB
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SORBITAN SESQUIOLEATE	0W8RRI5W5A	IACT
PETROLATUM	4T6H12BN9U	IACT

Source Document#

Source XML

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 44.

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
A211800-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB		2019-03-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A211800-001	AB

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211800-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2019-03-04	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A211800-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A211800-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211800-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211800-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211800-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211800-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211800-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211800-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211800-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211800-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211800-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211800-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211800-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211800-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211800-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211800-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211800-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211800-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211800-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211800-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211800-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211800-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211800-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211800-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211800-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211800-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211800-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211800-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211800-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211800-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211800-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211800-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211800-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211800-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211800-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211800-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211800-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211800-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211800-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211800-001	AB	1	`3a93d1ddd44b…`

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
a72ffd1b-3c1c-4c55-8e6a-ca372bd62829			51e83cde-7690-4df7-b882-36921aa5c87d	2025-02-27	Adverse reactions	Exact identifier spl set id: 51e83cde-7690-4df7-b882-36921aa5c87d

Reported adverse events (FAERS/openFDA)#

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