Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Selenium Sulfide 2.25% Shampoo is supplied in 6 fluid oz. (180 mL) bottles, NDC 16477-422-06. Store at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. 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. 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.; NDC 16477-422-06 Rx Only Selenium Sulfide 2.25% Shampoo 6 fluid oz. (180 mL) FOR TOPICAL USE ONLY NOT FOR OPTHALMIC USE LASER label 1 label 2 label 3
- HOW SUPPLIED: Selenium Sulfide 2.25% Shampoo is supplied in 6 fluid oz. (180 mL) bottles, NDC 16477-422-06. Store at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. 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. 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.
- NDC 16477-422-06 Rx Only Selenium Sulfide 2.25% Shampoo 6 fluid oz. (180 mL) FOR TOPICAL USE ONLY NOT FOR OPTHALMIC USE LASER label 1 label 2 label 3
Overview
DESCRIPTION: A liquid antiseborrheic, antifungal preparation for topical application. Each mL of Selenium Sulfide 2.25% Shampoo contains 22.5 mg selenium sulfide, and the following inactive ingredients: Alpha-tocopheryl acetate, ammonium lauryl sulfate, butylated hydroxytoluene, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, D&C yellow #10, FD&C red #40, fragrance, methylparaben, panthenol, propylene glycol, propylparaben, purified water, pyrithione zinc, sodium thiosulfate, stearyl alcohol, triacetin, urea, and 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: Generally 2 applications each week for 2 weeks will control symptoms. Subsequently, shampoo may be used less frequently – weekly, every 2 weeks, every 3 to 4 weeks or as directed by a physician. Should not be applied more frequently than necessary to maintain control. For tinea versicolor: Wet skin and apply to affected areas. Massage gently into skin working to a full lather. Allow product to remain on skin for 10 minutes, then rinse thoroughly. Repeat procedure once a day for seven days or as directed by a physician.
Warnings & Precautions
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.
Contraindications
: Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.
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.
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