Label: SELENIUM SULFIDE shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 42494-336-06 - Packager: Cameron Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated April 1, 2021
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- Official Label (Printer Friendly)
- FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
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DESCRIPTION:
Each mL contains 23 mg of selenium sulfide in a vehicle consisting of: ammonium lauryl sulfate, caprylic/capric triglyceride, chromium oxide green, citric acid, cocamidopropyl betaine, D&C yellow ...
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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 ...
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INDICATIONS:
Selenium Sulfide 2.3% Shampoo is a liquid antiseborrheic, antifungal preparation useful for the treatment of seborrheic dermatitis of the scalp, dandruff and tinea versicolor. Urea hydrates and is ...
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CONTRAINDICATIONS:
Selenium Sulfide 2.3% Shampoo is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
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WARNINGS:
PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Avoid contact with eyes, lips and mucous membranes. General: Selenium Sulfide 2.3% Shampoo is to be used as directed by a ...
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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 ...
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OVERDOSAGE:
There are no documented reports of serious toxicity in humans resulting from acute ingestion of this product. However, acute toxicity studies in animals suggest that ingestion of large amounts ...
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DOSAGE AND ADMINISTRATION:
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 ...
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HOW SUPPLIED:
Selenium Sulfide 2.3% Shampoo is supplied in a 6 fl. oz. (180 mL) bottle, NDC 42494-336-06.
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STORAGE:
Store at 20-25°C (68-77°F); excursions permitted between 15° and 30°C (59° and 86°F). See USP Controlled Room Temperature. Protect from freezing and excessive heat. Keep bottle tightly ...
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SPL UNCLASSIFIED SECTIONKEEP OUT OF REACH OF CHILDREN - Rx only - Manufactured for: Cameron Pharmaceuticals, LLC 1009 Twilight Trail - Frankfort, Kentucky 40601 - Rev. 08/2015
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Principal Display Panel - 180 mL Bottle CartonNDC 42494-336-06 - Selenium Sulfide 2.3% Shampoo - FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE - Cameron Pharmaceuticals™ Net wt. 6 fl. oz. (180 mL)
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INGREDIENTS AND APPEARANCEProduct Information