Selenium Sulfide

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

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.

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.

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.

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

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

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 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.

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.

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.

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

58657-478-06

Rx Only

SELENIUM

SULFIDE

2.25%

Shampoo

with urea and

zinc pyrithione

6 fl oz (180 mL)

label