Source: FDA, National Drug Code (US) Revision Year: 2020
Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.
For external use only. Not for ophthalmic use.
DO NOT USE ON BROKEN SKIN OR INFLAMED AREAS. If allergic reaction occurs, discontinue use. Avoid contact with eyes, genital areas and skin folds, as irritation and burning may result. If accidental contact occurs, rinse thoroughly with water. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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.
This medication is to be used as directed by a physician. Not to be used when inflammation or exudation is present as increased absorption may occur.
CATEGORY C.
Animal reproduction studies have not been conducted with this medication. It is also not known whether this product can cause fetal harm when applied to the body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances, selenium sulfide 2.3% shampoo should not be used by pregnant women.
It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Safety and effectiveness in children have not been established.
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