Label: SELENIUM SULFIDE lotion
- NDC Code(s): 50090-0242-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 45802-040
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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APPLICATION INSTRUCTIONS
Keep tightly capped. SHAKE WELL BEFORE USING.
Product may damage jewelry; remove jewelry before use.
For treatment of dandruff and seborrheic dermatitis of the scalp:
1. Massage about 1 or 2 teaspoonsful of suspension into wet scalp.
2. Allow to remain on scalp for 2 to 3 minutes.
3. Rinse scalp thoroughly.
4. Repeat application and rinse thoroughly.
5. After treatment, wash hands well.
6. Repeat treatments as directed by physician.
For treatment of tinea versicolor:
1. Apply to affected areas and lather with a small amount of water.
2. Allow to remain on skin for 10 minutes.
3. Rinse body thoroughly.
4. Repeat this procedure once a day for seven days.
- DESCRIPTION
- CONTAINS:
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
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PRECAUTIONS
General -
Should not be used when acute inflammation or exudation is present as increased absorption may occur.
Information for Patients -
Application 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 Topical Suspension USP, 2.5% (Lotion) may produce skin irritation especially in the genital area and where skin folds occur. These areas should be thoroughly rinsed after application.
Carcinogenesis -
Studies in mice using dermal application of 25% and 50% solutions of 2.5% selenium sulfide topical suspension, over an 88 week period, indicated no carcinogenic effects.
Pregnancy -
WHEN 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 Topical Suspension USP, 2.5% (Lotion). It is also not known whether Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) should not be used for the treatment of tinea versicolor in pregnant women.
- ADVERSE REACTIONS
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OVERDOSAGE
Accidental Oral Ingestion
Selenium Sulfide Topical Suspension USP, 2.5% (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 Topical Suspension USP, 2.5% (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.
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DOSAGE AND ADMINISTRATION
See 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 suspension 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 seven days.
- HOW SUPPLIED
- WARNINGS AND PRECAUTIONS:
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- SELENIUM SULFIDE
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INGREDIENTS AND APPEARANCE
SELENIUM SULFIDE
selenium sulfide lotionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0242(NDC:45802-040) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE 2.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength BENTONITE (UNII: A3N5ZCN45C) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCOL STEARATE (UNII: 0324G66D0E) LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-0242-0 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089996 09/25/2006 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-0242)