The following Structured Product Label (SPL) was submitted to the FDA by Padagis Israel Pharmaceuticals Ltd for the product Selenium Sulfide (NDC 45802-040). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, application instructions, description, contains:, clinical pharmacology, indications and usage, contraindications, general -, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
For External Use Only
Shake Well Before Use
Rx Only
Manufactured By Perrigo, Bronx, NY 10457
Distributed By Perrigo
Allegan, MI 49010
Rev 01-17
Manufactured By Perrigo, Bronx, NY 10457
Distributed By Perrigo, Allegan, MI 49010
www.perrigo.com
Rev 01-17
:2J526 RC B5
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.
A liquid antiseborrheic, antifungal preparation for topical application. Selenium sulfide has the molecular formula SeS2 and has a molecular weight of 143.09.
Selenium sulfide 2.5%; bentonite, citric acid, cocoamphocarboxyglycinate, ethylene glycol monostearate, fragrance, glycerol monoricinoleate, lauramide DEA, sodium lauryl sulfate, sodium phosphate (monobasic), titanium dioxide, and water.
Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, thus reducing corneocyte production.
For the treatment of tinea versicolor, seborrheic dermatitis of the scalp, and dandruff.
This product should not be used by patients allergic to any of its components.
Should not be used when acute inflammation or exudation is present as increased absorption may occur.
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.
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.
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.
Safety and effectiveness in infants have not been established.
In 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.
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.
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.
Selenium Sulfide Topical Suspension USP, 2.5% (Lotion) is available as follows:
4 fl oz plastic bottle (NDC 45802-040-64).
For External Use Only. Do not use on broken skin or inflamed 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.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
For lot number and expiration date see label or bottom of container.
Rx Only
NDC 45802-040-64
Selenium Sulfide Topical Suspension USP, 2.5% (Lotion)
For External Use Only
Shake Well Before Use
: 2J526 RC F5
4 FL OZ
Peel Here
Selenium-sulfide-topical-suspension-usp (Selenium Sulfide Topical Suspension Usp)
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