|Dosage Form||Package Information||Links|
|LOTION||118 mL in 1 BOTTLE, PLASTIC (60432-528-04)||Label Information|
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.
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.
Selenium sulfide appears to have a cytostatic effect on cells of the epidermis and follicular epithelium, reducing corneocyte production.
For treatment of tinea versicolor, seborrheic dermatitis of scalp and treatment of dandruff.
Not to be used when acute inflammation or exudation is present as increased absorption may occur.
See Warnings and Precautions section under Application Instructions.
Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88 week period, indicated no carcinogenic effects.
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.
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.
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.
LOTION, USP 2.5%
DESCRIPTION: Selenium Sulfide Lotion, USP 2.5% is a
liquid antiseborrheic, antifungal preparation for topical
application, containing selenium sulfide 2.5% w/v in
aqueous suspension. Also contains: Amphoteric-2;
Bentonite, NF; Captan; Citric Acid, USP; D&C Yellow
#10; Ethylene Glycol Monostearate; Glyceryl
Monoricinoleate; Lauric Diethanolamide; Perfume;
Purified Water, USP; Sodium Lauryl Sulfate; Sodium
Phosphate Monobasic, USP and Titanium Dioxide, USP.
Additional prescribing information inside.
WARNING: KEEP OUT OF THE REACH OF CHILDREN.
FOR EXTERNAL USE ONLY.
Store at controlled room temperature, (15 - 30) °C
((59 - 86) °F) [see USP].
NET: 4 fl oz (118 mL)
Morton Grove, IL 60053
DO NOT USE IF INNER FOIL
SEAL PRINTED "SEALED
FOR YOUR PROTECTION"
IS BROKEN OR MISSING.
selenium sulfide lotion
|Labeler - Morton Grove Pharmaceuticals, Inc. (801897505)|