You are here: Home > Prescription(RX) Drugs > S > Selenium Sulfide (River's Edge Pharmaceuticals, Llc)

Name:Selenium Sulfide
Manufacturer:River's Edge Pharmaceuticals, Llc
Category:Prescription Marketed Drugs


Selenium Sulfide 2.25% Shampoo

SELENIUM SULFIDE  - selenium sulfide shampoo 
River's Edge Pharmaceuticals, LLC

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.

----------

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:

carton

SELENIUM SULFIDE 
selenium sulfide shampoo
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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
# Item Code Package Description Multilevel Packaging
1 NDC: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: 12/2010 River's Edge Pharmaceuticals, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


Copyright © 2017 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

Prescription Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback