Video: Latest Treatment for Hep C.

Selenos Shampoo

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.

Selenos™ Shampoo

Description

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.

Slideshow: The Demon Drink: Excess Alcohol Consumption and Your Health

Clinical Pharmacology

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

Pharmacokinetics

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.

Contraindications

Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.

Warnings

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.

Precautions

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.

Carcinogenesis

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.

Nursing Mothers

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.

Pediatric Use

Safety and effectiveness in children have not been established.

Adverse Reactions

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

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.

How supplied

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

picture
SELENOS  
selenium sulfide shampoo, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-472
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Selenium Sulfide (Selenium) Selenium Sulfide 0.0225 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
urea  
pyrithione zinc  
water  
edetate disodium  
propylene glycol  
diazolidinyl urea  
methylparaben  
propylparaben  
ammonium lauryl sulfate  
titanium dioxide  
medium-chain triglycerides  
D&C yellow no. 8  
FD&C red no. 40  
chromic oxide  
citric acid monohydrate  
sodium citrate  
cocamidopropyl betaine  
lauric diethanolamide  
magnesium aluminum silicate  
hypromelloses  
Product Characteristics
Color ORANGE (dark orange) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-472-68 180 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved Drug Other 01/01/2007 09/30/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Registrant - Harmony Labs, Inc. (105803274)
Establishment
Name Address ID/FEI Operations
Harmony Labs, Inc. 105803274 MANUFACTURE
Revised: 12/2010
 
Breckenridge Pharmaceutical, Inc.
Hide
(web3)