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

Selenium Sulfide 2.3% Shampoo

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DESCRIPTION: Each mL contains 23 mg of selenium sulfide in a vehicle consisting of: alpha-tocopherol acetate, ammonium lauryl sulfate, citrus fragrance, cocamidopropyl betaine, EDTA, FD&C red No. 40, FD&C yellow No. 10, methyl paraben, panthenol, propyl paraben, purified water, pyrithione zinc, urea, xanthan gum.

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:

This product is a liquid antiseborrheic, antifungal preparation useful 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:

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

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. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted 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 this product. 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 use.

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. The product may darken upon storage. Discoloration does not impair the efficacy or safety of the product. Keep container tightly closed.

HOW SUPPLIED:

This product is supplied in the following size(s): 6 fl. oz. (180 mL) bottles, NDC: 58657-479-06

To report a serious adverse event, please contact Method Pharmaceuticals at (877) 250-3427; email at contact@methodpharm.com; or call FDA at (800) FDA-1088.

Manufactured For:

Method Pharmaceuticals, LLC Fort Worth, Texas 76118

Rev. 02/2018

PRINCIPAL DISPLAY PANEL

NDC: 58657-479-06
Selenium
Sulfide 2.3%
Shampoo
with urea and zinc pyrithione
Shake Well
Rx Only
6 fl. oz. (180 mL)

INGREDIENTS AND APPEARANCE

SELENIUM SULFIDE 
selenium sulfide shampoo

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 58657-479
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)	SELENIUM SULFIDE	23 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETIC ACID (UNII: 9G34HU7RV0)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
PYRITHIONE ZINC (UNII: R953O2RHZ5)
UREA (UNII: 8W8T17847W)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58657-479-06	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/05/2018

Labeler - Method Pharmaceuticals, LLC (060216698)