Selenium Sulfide
Shampoo · Topical
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. 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.
Contraindications
This product should not be used by patients allergic to any of its components.
Warnings and precautions
WARNINGS AND PRECAUTIONS: 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.
Precautions
General - Should not be used when acute inflammation or exudation is present as increased absorption may occur. Information for Patients - 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 - 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 - 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 - Safety and effectiveness in infants have not been established.
Side effects
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.
Pregnancy
Pregnancy - 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 - Safety and effectiveness in infants have not been established.
Overdosage
Accidental Oral Ingestion- 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.
Description
DESCRIPTION A liquid antiseborrheic, antifungal preparation for topical application. Selenium sulfide has the molecular formula SeS 2 and has a molecular weight of 143.09.
How supplied
Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is available as follows: 4 fl oz plastic bottle (NDC 45802- 040 -64).
Storage
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Patient information
Information for Patients - 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.
Label text from the FDA structured product label by Padagis Israel Pharmaceuticals Ltd (revised May 31, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Selenium Sulfide in 6 products
Selenium Sulfide NDC products (6)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 45802-040 | Selenium Sulfide 2.5 mg/100mL Lotion | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 24470-960 | Selenium Sulfide 23 mg/mL Shampoo | Cintex Services, LLC | UNAPPROVED DRUG OTHER |
| 52187-550 | Selenium Sulfide 23 mg/mL Shampoo | KMM Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 16477-422 | Selenium Sulfide 22.5 mg/mL Shampoo | Laser Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 16477-423 | Selenium Sulfide 23 mg/mL Shampoo | Laser Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 69367-229 | Selenium Sulfide 22.5 mg/mL Shampoo | Westminster Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Selenium Sulfide used for?
For the treatment of tinea versicolor, seborrheic dermatitis of the scalp, and dandruff.
What are the side effects of Selenium Sulfide?
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. See the full label for the complete list.
Who makes Selenium Sulfide?
Selenium Sulfide is listed by 5 labelers in the FDA NDC directory, including Padagis Israel Pharmaceuticals Ltd, Cintex Services, LLC, KMM Pharmaceuticals, LLC, Laser Pharmaceuticals, LLC.