Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: This product is supplied in the following size(s): 6 fl. oz. (180 mL) bottles, NDC 52187-550-06 To report a serious adverse event or obtain product information, call 1-855-899-4237. Distributed by: KMM Pharmaceuticals, LLC 1000 N. West Street Suite 1200, #1021 Wilmington, DE 19801 2100535 [00] Rev. 11/2021; label
- HOW SUPPLIED: This product is supplied in the following size(s): 6 fl. oz. (180 mL) bottles, NDC 52187-550-06 To report a serious adverse event or obtain product information, call 1-855-899-4237. Distributed by: KMM Pharmaceuticals, LLC 1000 N. West Street Suite 1200, #1021 Wilmington, DE 19801 2100535 [00] Rev. 11/2021
- label
Overview
Each mL contains 23 mg of selenium sulfide in a vehicle consisting of: D&C yellow #8, FD&C red #40, fragrance, methyl paraben, PEG-150 pentaerythrityl tetrastearate (and) aqua (and) PEG-6 caprylic/capric glycerides, propyl paraben, propylene glycol, purified water, sodium chloride, sodium laureth sulfate (and) cocamidopropyl betaine (and) sodium lauryl sulfate (and) cocamide MIPA, titanium dioxide, urea and zinc pyrithione.
Indications & Usage
INDICATIONS: This product 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.
Dosage & Administration
: Shake well before use. 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.
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.
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. The product may darken upon storage. Discoloration does not impair the efficacy or safety of the product. Keep container tightly closed.
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