SELENIUM SULFIDE LOTION, USP 2.5%
SPL UNCLASSIFIED SECTION
SHAKE WELL BEFORE USING.
APPLICATION INSTRUCTIONS
Keep tightly capped. SHAKE WELL BEFORE USING. Product may damage jewelry; remove jewelry before use.
For treatment of tinea versicolor:
For treatment of dandruff and seborrheic dermatitis of the scalp.
- Apply to affected areas and lather with a small amount of water.
- Allow to remain on skin for 10 minutes.
- Rinse body thoroughly.
- Repeat this procedure once a day for 7 days.
WARNINGS AND PRECAUTIONS
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.
FOR EXTERNAL USE ONLY. WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at controlled room temperature, (15 - 30) °C ((59 - 86) °F) [see USP].
CLINICAL PHARMACOLOGY
Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, reducing corneocyte production.
INDICATIONS AND USAGE
For treatment of tinea versicolor, seborrheic dermatitis of scalp and treatment of dandruff.
CONTRAINDICATIONS
Not to be used by patients allergic to any of its ingredients.
PRECAUTIONS
General:
Not to be used when acute inflammation or exudation is present as increased absorption may occur.
Information for Patients:
See Warnings and Precautions section under Application Instructions.
Carcinogenesis:
Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88 week period, indicated no carcinogenic effects.
Pregnancy:
WHEN USED ON BODY SURFACES FOR THE TREATMENT OF TINEA VERSICOLOR, SELENIUM SULFIDE LOTION, USP 2.5% IS CLASSIFIED AS PREGNANCY CATEGORY C. Animal reproduction studies have not been conducted with selenium sulfide. It is also not known whether selenium sulfide can cause fetal harm when applied to body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances selenium sulfide should not be used for the treatment of tinea versicolor in pregnant women.
Pediatric Use:
Safety and effectiveness in infants have not been established.
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.
OVERDOSAGE
Accidental Oral Ingestion:
No documented reports of serious toxicity in humans resulting from acute ingestion of selenium sulfide, however, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. Evacuation of the stomach contents should be considered in cases of acute oral ingestion.
DOSAGE AND ADMINISTRATION
See Application Instructions.
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 procedure once a day for 7 days.
For treatment of dandruff and seborrheic dermatitis
Usually 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 every 3 or 4 weeks in some cases. Should not be applied more frequently than required to maintain control.
HOW SUPPLIED
Selenium Sulfide Lotion, USP 2.5% is supplied in 4 fl oz (118 mL) bottles.
PROTECT FROM HEAT. FOR EXTERNAL USE ONLY.
WARNINGS
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Rx Only
Product No.: 8528
A50-8528-04
REV. 01-05
Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053