Generic Name: selenium sulfide
Dosage Form: shampoo, suspension
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
A liquid antiseborrheic, antifungal preparation for topical application. Each gram of Selenos™ Shampoo contains 22.5 mg selenium sulfide, urea, zinc pyrithione, purified water, edetate disodium, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, hydroxypropyl methylcellulose, ammonium lauryl sulfate, titanium dioxide, caprylic/capric triglyceride, D&C yellow #8, FD&C red #40, chromium oxide greens, citric acid, sodium citrate, cocamidopropyl betaine, lauramide DEA, magnesium aluminum silicate and fragrance.
Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, reducing corneocyte production.
The mechanism of action of topically applied selenium sulfide is not yet known.
Indications and Uses
A liquid antiseborrheic, antifungal preparation to treat seborrheic dermatitis of the scalp, dandruff and tinea versicolor. Urea hydrates and is useful for conditions such as dry scalp.
Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.
For external use only. Not for ophthalmic use. DO NOT USE ON BROKEN SKIN OR INFLAMED AREAS.
If allergic reaction occurs, discontinue use. Avoid contact with eyes, genital areas and skin folds, as irritation and burning may result. If accidental contact occurs, rinse thoroughly with water after application.
This medication is to be used as directed by a physician. Do not use when inflammation or exudation is present as increased absorption may occur.
Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects.
Use in Pregnancy
Category C. Animal reproduction studies have not been conducted with Selenos™ Shampoo. It is also not known whether Selenos™ Shampoo can cause fetal harm when applied to the body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances, Selenos™ Shampoo should not be used by pregnant women.
It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Selenos™ Shampoo is administered to a nursing woman.
Safety and effectiveness in children have not been established.
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.
There are no documented reports of serious toxicity in humans resulting from acute ingestion of Selenos™ Shampoo. 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
For seborrheic dermatitis and dandruff: Generally 2 applications each week for 2 weeks will usually control symptoms. After 2 weeks, shampoo may be used less frequently: weekly, every 2 weeks, every 3 to 4 weeks or as directed by a physician. Do not apply more frequently than necessary to maintain control. For tinea versicolor: Apply to affected areas and lather with a small amount of water. Rinse thoroughly after 10 minutes. Repeat procedure once a day for 7 days or as directed by a physician.
Selenos™ Shampoo (Selenium Sulfide 2.25%) is supplied in 180 ml bottles, NDC 51991-472-68.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°F-86°F). See USP Controlled Room Temperature. Protect from freezing.
Warning: Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately.
Do not accept if plastic safety shell has been removed or broken.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Manufactured by: Harmony Labs, Inc., Landis, NC 28088
Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487
selenium sulfide shampoo, suspension
|Labeler - Breckenridge Pharmaceutical, Inc. (150554335)|
|Registrant - Harmony Labs, Inc. (105803274)|
|Harmony Labs, Inc.||105803274||MANUFACTURE|