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|Selenium Selenium |
| Drugs search, click the first letter of a drug name: | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9 Home SeleniumGeneric Name: Selenium sulfide Dosage Form: Lotion NDC 45802-040-64 Rx only FOR EXTERNAL USE ONLY Store at controlled room temperature 15°-30° C (59° - 86°F). Lot No. & Exp. Date: See label or bottom of container. Selenium DescriptionA liquid antiseborrheic, antifungal preparation for topical application. Selenium Sulfide has the formula SeS2 and has a molecular weight of 143.08. CONTAINSSelenium Sulfide 2.5%, Purified Water, Sodium Lauryl Sulfate, Ethylene Glycol Monostearate, Titanium Dioxide, Cocoamphocarboxyglycinate, Lauramide DEA, Bentonite, Sodium Phosphate (monobasic), Glyceryl Monoricinoleate, Fragrance, Citric Acid. Selenium - Clinical PharmacologySelenium Sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, thus reducing corneocyte production. INDICATION AND USAGEFor the treatment of dandruff and seborrheic dermatitis of the scalp. For treatment of tinea versicolor. ContraindicationsThis product should not be used by patients allergic to any of its components. PrecautionsGeneralShould not be used when acute inflammation or exudation is present as increased absorption may occur. Information for PatientsApplication to skin or scalp may produce skin irritation or sensitization. If sensitivity reactions occur, use should be discontinued. May be irritating to mucous membranes of the eyes and contact with this area should be avoided. When applied to the body for treatment of tinea versicolor, Selenium Sulfide Lotion, USP 2.5% may produce skin irritation especially in the genital area and where skin folds occur. These areas should be thoroughly rinsed after application. CarcinogenesisStudies in mice using dermal application of 25% and 50% solutions of 2.5% Selenium Sulfide Lotion, over an 88 week period, indicated no carcinogenic effects. PregnancyWHEN USED ON BODY SURFACES FOR THE TREATMENT OF TINEA VERSICOLOR, Selenium SULFIDE IS CLASSIFIED AS PREGNANCY CATEGORY "C". Animal reproduction studies have not been conducted with Selenium Sulfide Lotion. It is also not known whether Selenium Sulfide Lotion can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances Selenium Sulfide Lotion should not be used for the treatment of tinea versicolor in pregnant women. Pediatric UseSafety and effectiveness in infants have not been established. Adverse ReactionsIn decreasing order of severity: skin irritation, occasional reports of increase in amount of 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. OverdosageAccidental Oral IngestionSelenium Sulfide Lotion is intended for external use only. There have been no documented reports of serious toxicity in humans resulting from acute ingestion of Selenium Sulfide Lotion, however, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. For this reason, evacuation of the stomach contents should be considered in cases of acute oral ingestion. Selenium Dosage and AdministrationSee application instructions on rear panel of this bottle. For treatment of dandruff and seborrheic dermatitis: For the usual case, two applications each week for two weeks will afford control. After this, the lotion may be used at less frequent intervals - weekly, every two weeks, or even every 3 or 4 weeks in some cases. The preparation should not be applied more frequently than required to maintain control. For treatment of tinea versicolor: Apply to affected areas and lather with a small amount of water. Allow product to remain on skin for 10 minutes, then rinse the body thoroughly. Repeat this procedure once a day for 7 days. How is Selenium SuppliedSelenium Sulfide Lotion, USP 2.5% is available in 4 fl oz plastic bottles. Mfg. By: CLAY-PARK LABS, INC., Bronx, NY 10457 LCPL04054-2B R0504 APPLICATION INSTRUCTIONS Keep tightly capped. SHAKE WELL BEFORE USING. For treatment of dandruff and seborrheic dermatitis of the scalp:
For treatment of tinea versicolor:
WARNINGS AND PRECAUTIONS: For External Use Only. Do not use on broken skin or infected areas. If allergic reactions occur, discontinue use. Avoid getting shampoo in eyes or in contact with genital area as it may cause irritation and burning. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. Mfg. By: CLAY-PARK LABS, INC., Bronx, NY 10457 R04DS4CPL-2B
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