Selenium Sulfide Topical Suspension USP, 2.5% (Lotion)

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2021-06-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:36:58

Label at a glance#

ProductSELENIUM SULFIDE
Active ingredientSELENIUM SULFIDE
Label structure17 sections

Indications and uses

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

Dosage and administration

See application instructions on rear panel of this bottle. For treatment of dandruff and seborrheic dermatitis: For the usual case, two applications each week for two weeks will afford control. After this, the suspension may be used at less frequent intervals - weekly, every two weeks, or even every 3 or 4 weeks in some cases. The preparation should not be applied more frequently than required to maintain control....

Storage and handling

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. For lot number and expiration date see label or bottom of container.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For External Use Only

Shake Well Before Use

Rx Only

APPLICATION INSTRUCTIONS

SPL UNCLASSIFIED SECTION

Keep tightly capped. SHAKE WELL BEFORE USING.

Product may damage jewelry; remove jewelry before use.

For treatment of dandruff and seborrheic dermatitis of the scalp:

1. Massage about 1 or 2 teaspoonsful of suspension into wet scalp.

2. Allow to remain on scalp for 2 to 3 minutes.

3. Rinse scalp thoroughly.

4. Repeat application and rinse thoroughly.

5. After treatment, wash hands well.

6. Repeat treatments as directed by physician.

For treatment of tinea versicolor:

1. Apply to affected areas and lather with a small amount of water.

2. Allow to remain on skin for 10 minutes.

3. Rinse body thoroughly.

4. Repeat this procedure once a day for seven days.

DESCRIPTION

DESCRIPTION SECTION

A liquid antiseborrheic, antifungal preparation for topical application. Selenium sulfide has the molecular formula SeS 2 and has a molecular weight of 143.09.

CONTAINS:

SPL UNCLASSIFIED SECTION

Selenium sulfide 2.5%; bentonite, citric acid, cocoamphocarboxyglycinate, ethylene glycol monostearate, fragrance, glycerol monoricinoleate, lauramide DEA, sodium lauryl sulfate, sodium phosphate (monobasic), titanium dioxide, and water.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

This product should not be used by patients allergic to any of its components.

PRECAUTIONS

PRECAUTIONS SECTION

General -

GENERAL PRECAUTIONS SECTION

Should not be used when acute inflammation or exudation is present as increased absorption may occur.

Information for Patients -

INFORMATION FOR PATIENTS SECTION

Application to skin or scalp may produce skin irritation or sensitization. If sensitivity reactions occur, use should be discontinued. May be irritating to mucous membranes of the eyes and contact with this area should be avoided. When applied to the body for treatment of tinea versicolor, Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) may produce skin irritation especially in the genital area and where skin folds occur. These areas should be thoroughly rinsed after application.

Carcinogenesis -

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Studies in mice using dermal application of 25% and 50% solutions of 2.5% selenium sulfide topical suspension, 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 IS CLASSIFIED AS PREGNANCY CATEGORY "C". Animal reproduction studies have not been conducted with Selenium Sulfide Topical Suspension USP, 2.5% (Lotion). It is also not known whether Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) 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 amount of 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

Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is intended for external use only. There have been no documented reports of serious toxicity in humans resulting from acute ingestion of Selenium Sulfide Topical Suspension USP, 2.5% (Lotion); however, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. For this reason, evacuation of the stomach contents should be considered in cases of acute oral ingestion.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

See application instructions on rear panel of this bottle. For treatment of dandruff and seborrheic dermatitis: For the usual case, two applications each week for two weeks will afford control. After this, the suspension may be used at less frequent intervals - weekly, every two weeks, or even every 3 or 4 weeks in some cases. The preparation should not be applied more frequently than required to maintain control.

For treatment of tinea versicolor: 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 this procedure once a day for seven days.

HOW SUPPLIED

HOW SUPPLIED SECTION

Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is available as follows:

4 fl oz plastic bottle (NDC 68071-1768-4).

SPL UNCLASSIFIED SECTION

Manufactured By Perrigo, Bronx, NY 10457

Distributed By Perrigo

Allegan, MI 49010

Rev 01-17

WARNINGS AND PRECAUTIONS:

WARNINGS AND 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.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

STORAGE AND HANDLING SECTION

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

For lot number and expiration date see label or bottom of container.

SPL UNCLASSIFIED SECTION

Manufactured By Perrigo, Bronx, NY 10457

Distributed By Perrigo, Allegan, MI 49010

www.perrigo.com

Rev 01-17

:2J526 RC B5

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1768-42023-01-30C16284748780-1f386c64a-2366-0266-e053-dadaa90a7c1aSelenium Sulfide Topical Suspension USP, 2.5% (Lotion)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1768-4SELENIUM SULFIDE118 mL in 1 BOTTLELOTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1768SELENIUM SULFIDE LOTION [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20210611_c46d25b5-d2db-61a3-e053-2a95a90a86d7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-040-64ML - Milliliter45802-0406af7df0a-b6f8-44b9-a00d-990f4651fe3612013-02-13

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-176868071-1768-4
45802-040

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089996-001SELENIUM SULFIDESELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-1084e616aacf4f…
2026-08-18 06:07:402026-07A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-103f01610625f2…
2019-09-15 20:21 UTC2019-09A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALATRS1991-01-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089996-001SELENIUM SULFIDE2.5%LOTION/SHAMPOO / TOPICALRS1991-01-10f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089996-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089996-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089996-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089996-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089996-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089996-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089996-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A089996-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089996-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089996-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089996-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A089996-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089996-001AT1ea99ee380514…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SELENIUM SULFIDESELENIUM SULFIDEPadagis Israel Pharmaceuticals Ltd28b84e3c-ae44-40bb-93c4-2625e19f7e612025-05-31Warnings, Adverse reactionsExact identifier
ndc (product): 45802-040
c46d2f34-29cb-11fc-e053-2a95a90a84abc46d25b5-d2db-61a3-e053-2a95a90a86d72021-06-10Warnings, Adverse reactionsExact identifier
spl id: c46d2f34-29cb-11fc-e053-2a95a90a84ab
spl set id: c46d25b5-d2db-61a3-e053-2a95a90a86d7

Reported adverse events (FAERS/openFDA)#

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