SELENIUM SULFIDE shampoo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q)

Available from:

Bryant Ranch Prepack

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Selenium Sulfide 2.3% Shampoo 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. Selenium Sulfide 2.3% Shampoo is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

Product summary:

Selenium Sulfide 2.3% Shampoo is supplied in a 6 fl. oz. (180 mL) bottle, NDC 63629-2002-1.

Authorization status:

unapproved drug other

Summary of Product characteristics

SELENIUM SULFIDE- SELENIUM SULFIDE SHAMPOO
BRYANT RANCH PREPACK
_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._
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SELENIUM SULFIDE
2.3% SHAMPOO
​FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
​DESCRIPTION:
Each mL contains 23 mg of selenium sulfide in a vehicle consisting of:
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, fragrance, hydroxypropyl methylcellulose, magnesium aluminum
silicate,
methylparaben, panthenol, PPG-2 hydroxyethyl coco/isostearamide,
propylene glycol,
propylparaben, purified water, FD&C red no 40, 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:
Selenium Sulfide 2.3% Shampoo 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:
Selenium Sulfide 2.3% Shampoo is contraindicated in persons with known
or suspected
hypersensitivity to any of the ingredients of the product.
WARNINGS:
PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
AVOID CONTACT WITH EYES, LIPS AND MUCOUS MEMBRANES.
GENERAL:
Selenium Sulfide 2.3% Shampoo is to be used as directed by a licensed
medical
practitioner 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 licensed
medical practitioner.
INFORMATION FOR PATIENTS:
Patients should discontinu