Selenium Sulfide Shampoo

Dosage Form: shampoo
Selenium Sulfide 2.25% Shampoo

DESCRIPTION:

A liquid antiseborrheic, antifungal preparation for topical application.

INGREDIENTS:

River’s Edge Selenium Sulfide 2.25% Shampoo contains Selenium Sulfide 2.25%, Ammonium Lauryl Sulfate, Caprylic/Capric Triglyceride, Chromium Oxide Green, Citric Acid, Cocamidopropyl Betaine, D and C Yellow No. 8, Diazolidinyl Urea, Edetate Disodium, FD and 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 AND 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:

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. These areas should be thoroughly rinsed with water after application.

PRECAUTIONS:

This medication is to be used as directed by a physician. Not to be used 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 River’s Edge Selenium Sulfide 2.25% Shampoo. It is also not known whether Selenium Sulfide 2.25% Shampoo can cause fetal harm when applied to the body surfaces of a pregnant woman or can affect reproduction capacity. 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 River’s Edge Selenium Sulfide 2.25% Shampoo is administered to nursing women.

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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

OVERDOSAGE:

No documented reports of serious toxicity in humans resulting from acute ingestion of River’s Edge 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:

For seborrheic dermatitis and dandruff: Generally 2 applications each week for 2 weeks will control symptoms. Subsequently, shampoo may be used less frequently – weekly, every 2 weeks, every 3 to 4 weeks or as directed by a physician. Should not be applied more frequently than necessary to maintain control.

For tinea versicolor: Apply to affected areas and lather with a small amount of water. Allow product to remain on skin for 10 minutes, then rinse thoroughly. Repeat procedure once a day for seven days or as directed by a physician.

HOW SUPPLIED:

River’s Edge Selenium Sulfide 2.25% Shampoo is supplied in a 180 mL bottle, NDC 68032-127-18.

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

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

PACKAGING:

SELENIUM SULFIDE  selenium sulfide  shampoo

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-127 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength AMMONIUM LAURYL SULFATE   MEDIUM-CHAIN TRIGLYCERIDES   CHROMIC OXIDE   ANHYDROUS CITRIC ACID   COCAMIDOPROPYL BETAINE   D&C YELLOW NO. 8   DIAZOLIDINYL UREA   EDETATE DISODIUM   FD&C RED NO. 40   HYPROMELLOSE 2208 (100 MPA.S)   MAGNESIUM ALUMINUM SILICATE   METHYLPARABEN   PANTHENOL   PROPYLENE GLYCOL   PROPYLPARABEN   WATER   SODIUM CITRATE   TITANIUM DIOXIDE   UREA   PYRITHIONE ZINC

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-127-18 180 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/08/2008	10/31/2012

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2010River's Edge Pharmaceuticals, LLC

More Selenium Sulfide Shampoo resources

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