SELENIUM SULFIDE 2.5% LOTION

Manufacturer: Central Texas Community Health Centers
Effective date: 2016-01-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:21:54

Label at a glance#

ProductSelenium Sulfide

Active ingredientSelenium Sulfide

Label structure13 sections

Dosage and administration

See Application Instructions .

Storage and handling

Store at controlled room temperature, (15 - 30) °C ((59 - 86) °F) [see USP].

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SHAKE WELL BEFORE USING.

APPLICATION INSTRUCTIONS

SPL UNCLASSIFIED SECTION

Keep tightly capped. SHAKE WELL BEFORE USING. Product may damage jewelry; remove jewelry before use.

For treatment of tinea versicolor:

Apply to affected areas and lather with a small amount of water.
Allow to remain on skin for 10 minutes.
Rinse body thoroughly.
Repeat this procedure once a day for 7 days.

For treatment of dandruff and seborrheic dermatitis of the scalp.

Massage 1 or 2 teaspoonfuls of shampoo into wet scalp.
Allow to remain on scalp for 2 to 3 minutes.
Rinse scalp thoroughly.
Repeat application and rinse thoroughly.
After treatment, wash hands well.
Repeat treatments as directed by physician.

WARNINGS AND PRECAUTIONS:

PRECAUTIONS SECTION

For External Use Only. Do not use on broken skin or inflamed areas. If allergic reactions occur, discontinue use. Avoid getting shampoo in eyes or in contact with genital area as it may cause irritation and burning.

FOR EXTERNAL USE ONLY. WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

STORAGE AND HANDLING SECTION

Store at controlled room temperature, (15 - 30) °C ((59 - 86) °F) [see USP].

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

MECHANISM OF ACTION SECTION

Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, reducing corneocyte production.

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

For treatment of tinea versicolor, seborrheic dermatitis of scalp and treatment of dandruff.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

Not to be used by patients allergic to any of its ingredients.

PRECAUTIONS:

PRECAUTIONS SECTION

General:

GENERAL PRECAUTIONS SECTION

Not to be used when acute inflammation or exudation is present as increased absorption may occur.

Information for Patients:

INFORMATION FOR PATIENTS SECTION

See Warnings and Precautions section under Application Instructions.

Carcinogenesis:

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88 week period, indicated no carcinogenic effects.

Pregnancy:

PREGNANCY SECTION

WHEN USED ON BODY SURFACES FOR THE TREATMENT OF TINEA VERSICOLOR, SELENIUM SULFIDE LOTION, USP 2.5% IS CLASSIFIED AS PREGNANCY CATEGORY C. Animal reproduction studies have not been conducted with selenium sulfide. It is also not known whether selenium sulfide can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances selenium sulfide should not be used for the treatment of tinea versicolor in pregnant women.

Pediatric Use:

PEDIATRIC USE SECTION

Safety and effectiveness in infants have not been established.

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

In decreasing order of severity: skin irritation; occasional reports of increase in normal hair loss; discoloration of hair (can be avoided or minimized by thorough rinsing of hair after treatment). As with other shampoos, oiliness or dryness of hair and scalp may occur.

OVERDOSAGE:

OVERDOSAGE SECTION

Accidental Oral Ingestion:

SPL UNCLASSIFIED SECTION

No documented reports of serious toxicity in humans resulting from acute ingestion of selenium sulfide, however, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. Evacuation of the stomach contents should be considered in cases of acute oral ingestion.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

See Application Instructions.

For treatment of tinea versicolor:

SPL UNCLASSIFIED SECTION

Apply to affected areas and lather with a small amount of water. Allow product to remain on skin for 10 minutes, then rinse the body thoroughly. Repeat procedure once a day for 7 days.

For treatment of dandruff and seborrheic dermatitis:

SPL UNCLASSIFIED SECTION

Usually two applications each week for two weeks will afford control. After this, the lotion may be used at less frequent intervals – weekly, every two weeks, or every 3 or 4 weeks in some cases. Should not be applied more frequently than required to maintain control.

HOW SUPPLIED

HOW SUPPLIED SECTION

Selenium Sulfide Lotion, USP 2.5% is supplied in 4 fl oz (118 mL) bottles.

PROTECT FROM HEAT. FOR EXTERNAL USE ONLY.

WARNINGS

WARNINGS SECTION

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

SPL UNCLASSIFIED SECTION

Rx Only

Product No.: 8528
A50-8528-04
REV. 01-05

Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053

PRINCIPAL DISPLAY PANEL - 118 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CommUnityCare Federally Qualified Health Centers

SELENIUM
SULFIDE
2.5 %
LOTION

Date:

Name:
Dr.

SHAKE WELL AND USE AS DIRECTED BY DOCTOR**FOR
EXTERNAL USE ONLY**

lot number

exp date

SELENIUM SULFIDE 2.5% LOTION 118ML NDC 76413-123-01

Batch. batch number
Lot: lot number
Exp: exp date
MGP

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL - 118 ML Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238600	selenium sulfide 2.5 % Topical Suspension	PSN	1
238600	selenium sulfide 25 MG/ML Medicated Shampoo	SCD	1
238600	selenium sulfide 2.5 % Lotion Shampoo	SY	1
238600	selenium sulfide 2.5 % Medicated Shampoo	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76413-123-01	2020-01-31	C162847	48780-1	9d75b9d0-8137-f424-e053-dadaa90a57ce	SELENIUM SULFIDE 2.5% LOTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76413-123-01	Selenium Sulfide	118 mL in 1 BOTTLE, PLASTIC	LOTION	118		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76413-123	SELENIUM SULFIDE LOTION [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]	1	Legacy NDC, 1 package rows	20160129_cb6fa437-95a8-4821-9dd0-3312112a9895.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60432-528-04	ML - Milliliter	60432-528	1ef92146-113c-46c0-8953-fdf2f4e5cbfd	1	2013-02-13
60432-528-05	ML - Milliliter	60432-528	a868770a-dea8-4884-9dfb-5ed30aaf2ac0	1	2019-04-11

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Selenium Sulfide
BENTONITE
TITANIUM DIOXIDE
WATER
ANHYDROUS CITRIC ACID
SODIUM PHOSPHATE, MONOBASIC
SODIUM LAURYL SULFATE
DISODIUM COCOAMPHODIACETATE
GLYCOL STEARATE
LAURIC DIETHANOLAMIDE
CASTOR OIL
CAPTAN
D&C YELLOW NO. 10

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76413-123	76413-123-01
60432-528

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Selenium Sulfide	Z69D9E381Q	ACTIB
BENTONITE	A3N5ZCN45C	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
DISODIUM COCOAMPHODIACETATE	18L9G3U51M	IACT
GLYCOL STEARATE	0324G66D0E	IACT
LAURIC DIETHANOLAMIDE	I29I2VHG38	IACT
CASTOR OIL	D5340Y2I9G	IACT
CAPTAN	EOL5G26Q9F	IACT
D&C YELLOW NO. 10	35SW5USQ3G	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
A088228-001	SELENIUM SULFIDE	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL			1983-09-01

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	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL	AT	1983-09-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088228-001	SELENIUM SULFIDE	2.5%	LOTION/SHAMPOO / TOPICAL		1983-09-01	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088228-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088228-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088228-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088228-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088228-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088228-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088228-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088228-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088228-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088228-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088228-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088228-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088228-001	AT	1	`ea99ee380514…`

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
8b34c079-f577-473b-b33d-f6395321fe90			cb6fa437-95a8-4821-9dd0-3312112a9895	2016-01-25	Warnings, Adverse reactions	Exact identifier spl id: 8b34c079-f577-473b-b33d-f6395321fe90 spl set id: cb6fa437-95a8-4821-9dd0-3312112a9895

Reported adverse events (FAERS/openFDA)#

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