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:

Laser Pharmaceuticals, LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS & 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. USE IN PREGNANCY: CATEGORY C Animal reproduction studies have not been conducted with this medication. It is also not known whether this product can cause fetal harm when applied to the body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances, selenium sulfide 2.3% shampoo should not be used by pregnant women. PEDIATRIC USE: Safety and effectiveness in children have not been established.

Product summary:

HOW SUPPLIED: Selenium Sulfide 2.3% Shampoo is supplied in 6 fluid oz. (180 mL) bottles, NDC 16477-423-06. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 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: The product may darken upon storage. Discoloration does not impair the efficacy or safety of the product. Keep container tightly closed. Protect from freezing. All prescription substitutions and / or recommendations using this product shall be made subject to state and federal statutes as applicable. Please NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, inactive ingredients (excipients) and other chemical information provided herein.

Authorization status:

unapproved drug other

Summary of Product characteristics

SELENIUM SULFIDE- SELENIUM SULFIDE SHAMPOO
LASER 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._
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SELENIUM SULFIDE 2.3% SHAMPOO
Rx only
SELENIUM SULFIDE
2.3% SHAMPOO
DESCRIPTION: A liquid antiseborrheic, antifungal preparation for
topical application.
Each mL of Selenium Sulfide 2.3% Shampoo contains 23.0 mg selenium
sulfide, and the
following inactive ingredients: butylated hydroxytoluene, cetyl
alcohol, citric acid,
cocamidopropyl betaine, disodium EDTA, D&C Yellow #10, FD&C Red #40,
fragrance,
panthenol, phenoxyethanol, propylene glycol, purified water, strearyl
alcohol, sodium
laureth sulfate, sodium thiosulfate, tocopheryl acetate, triacetin,
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 & 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. If accidental contact occurs, rinse thoroughly
with water. KEEP
THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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
CARCINOGENESIS: Dermal application of 25% and 50% solutions of 2.