SELENIUM SULFIDE shampoo

Selenium Sulfide by

Drug Labeling and Warnings

Selenium Sulfide by is a Prescription medication manufactured, distributed, or labeled by Method Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NDC: 58657-478-06
Rx Only
Selenium Sulfide
2.25% Shampoo
with urea and zinc pyrithione
6 fl oz (180 mL)

DESCRIPTION:

Each mL of Selenium Sulfide 2.25% Shampoo contains 22.5mg selenium sulfide, ammonium lauryl sulfate, caprylic/capric triglyceride, chromium oxide green, citric acid, cocamidopropyl betaine, D&C yellow No. 8, diazolidinyl urea, distearyl phthalic acid amide, edetate disodium, FD&C red No. 40, fragrance, hydroxypropyl methylcellulose, magnesium aluminum silicate, methylparaben, panthenol, PPG-2 hydroxyethyl coco/isostearamide, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide, tocopheryl acetate, urea and zinc pyrithione.

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 & USAGE:

A liquid antiseborrheic, antifungal preparation for the treatment of seborrheic dermatitis of the scalp, dandruff and tinea versicolor. Urea hydrates and is useful for conditions such as dry scalp.

CONTRAINDICATIONS:

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

WARNINGS:

KEEP OUT OF REACH OF CHILDREN. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

PRECAUTIONS:

General:

This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician.

Information for Patients:

Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes. If accidental contact occurs, rinse thoroughly with water. Do not use on broken skin or inflamed areas.

Carcinogenesis, Mutagenesis and Impairment of Fertility:

Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects. Studies on reproduction and fertility also have not been performed.

Pregnancy:

CATEGORY C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. Under ordinary circumstances, selenium sulfide 2.25% 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 this product is administered to a nursing woman.

Pediatric use: Safety and effectiveness in children under the age of 12 years 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 selenium sulfide 2.25% 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:

SHAKE WELL BEFORE USING

For seborrheic dermatitis and dandruff: Wet skin and apply to areas to be cleansed. Massage gently into the skin working into a full lather. Rinse thoroughly and pat dry. Generally two applications each week for two weeks will control symptoms. Subsequently, shampoo may be used less frequently, or as directed by a physician. It should not be applied more frequently than necessary to maintain control.

For tinea versicolor: Wet skin and apply to areas to be cleansed. Massage gently into the skin working into a full lather. Allow product to remain on skin for ten minutes, then rinse thoroughly and pat dry. Repeat procedure once a day for seven days or as directed by a physician.

STORAGE:

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.

NOTICE: Protect from freezing and excessive heat. Keep bottle tightly closed.

HOW SUPPLIED: 

Selenium Sulfide 2.25% Shampoo is supplied in 180 mL bottles, NDC: 58657-478-06.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for:
Method Pharmaceuticals, LLC
Arlington, TX 76006
www.methodpharm.com

Rev. 3/15

PRINCIPAL DISPLAY PANEL

58657-478-06
Rx Only
SELENIUM
SULFIDE
2.25%
Shampoo
with urea and
zinc pyrithione
6 fl oz (180 mL)

INGREDIENTS AND APPEARANCE

SELENIUM SULFIDE 
selenium sulfide shampoo

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 58657-478
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	22.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
PANTHENOL (UNII: WV9CM0O67Z)
PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE (UNII: EK4J71ZKEQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UREA (UNII: 8W8T17847W)
PYRITHIONE ZINC (UNII: R953O2RHZ5)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CHROMIC OXIDE (UNII: X5Z09SU859)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
FLUORESCEIN SODIUM (UNII: 93X55PE38X)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58657-478-06	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2015

Labeler - Method Pharmaceuticals, LLC (060216698)