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:

Bi-Coastal Pharma International LLC

INN (International Name):

Selenium Sulfide

Composition:

Selenium Sulfide 22.5 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.

Product summary:

Selenium Sulfide 2.25% Shampoo is supplied in 180 mL bottles, NDC 42582-900-06. 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. Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

unapproved drug other

Summary of Product characteristics

SELENIUM SULFIDE- SELENIUM SULFIDE SHAMPOO
BI-COASTAL PHARMA INTERNATIONAL 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
2.25% SHAMPOO
Rx Only
DIRECTIONS
A liquid antiseborrehic, antifungal preparation for topical
application.
Each mL of Selenium Sulfide 2.25% Shampoo contains 22.5 mg selenium
sulfide,
ammonium lauryl sulfate, caprylic/capric triglyceride, chromium oxide
green, citric acid,
cocamidopropyl betaine, D&C yellow #8, diazolidinyl urea, edetate
disodium, FD&C red
#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,
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 & 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.
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% selen