Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Selenium Sulfide 2.25% Shampoo is supplied in 180mL bottles, NDC 69367-229-18. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.; PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label NDC 69367-229-18 Rx Only SELENIUM SULFIDE 2.25% Shampoo with urea and zinc pyrithione 6 fl. oz. (180 mL) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
- HOW SUPPLIED Selenium Sulfide 2.25% Shampoo is supplied in 180mL bottles, NDC 69367-229-18. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
- PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label NDC 69367-229-18 Rx Only SELENIUM SULFIDE 2.25% Shampoo with urea and zinc pyrithione 6 fl. oz. (180 mL) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
Overview
Each mL of Selenium Sulfide 2.25% Shampoo contains 22.5mg selenium sulfide, and the following inactive ingredients: butylated hydroxytoluene, cetyl alcohol, citric acid, cocamidopropyl betaine, disodium EDTA, D&C yellow No. 10, FD&C red No. 40, fragrance, panthenol, phenoxyethanol, propylene glycol, purified water, pyrithione zinc, sodium laureth sulfate, sodium thiosulfate, stearyl alcohol, tocopherol acetate, triacetin, urea, xanthan gum.
Indications & Usage
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.
Dosage & Administration
SHAKE WELL BEFORE USING For seborrheic dermatitis and dandruff Wet skin and apply to areas to be cleansed. Massage gently into the skin working into a full lather. Rinse thoroughly and pat dry. Generally two applications each week for two weeks will control symptoms. Subsequently, shampoo may be used less frequently, or as directed by a physician. It should not be applied more frequently than necessary to maintain control. For tinea versicolor Wet skin and apply to areas to be cleansed. Massage gently into the skin working into a full lather. Allow product to remain on skin for ten minutes, then rinse thoroughly and pat dry. Repeat procedure once a day for seven days or as directed by a physician.
Warnings & Precautions
WARNINGS KEEP OUT OF REACH OF CHILDREN. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Contraindications
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
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. To report a serious adverse event, please contact Westminster Pharmaceuticals at 1-844-221-7294 or call FDA at 1-800-FDA-1088 or fda.gov/medwatch.
Storage & Handling
STORAGE Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 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: Protect from freezing and excessive heat. Keep bottle tightly closed.
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