Registrants (1)
620885173
Products (1)
DermaZinc
35324-003
M032
OTC Monograph Drug (C200263)
TOPICAL
May 25, 2025
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
For relief of the symptoms of seborrheic dermatitis and dandruff.
DOSAGE & ADMINISTRATION SECTION
Apply to wet hair and massage into hair and scalp; rinse thoroughly
For best results use at least twice a week or as directed by a doctor.
WARNINGS SECTION
Warnings
■ For external use only.
■ Ask a doctor before use if you have a condition that covers a large area of
the body.
When using this product avoid contact with the eyes. If contact occurs, rinse
eyes thoroughly with
water.
Stop use and ask a doctor if condition worsens or does not improve after
regular use of this
product as directed.
If pregnant or breast-feeding, ask a health professional before use. Keep out
of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
OTC - ACTIVE INGREDIENT SECTION
Pyrithione Zinc 2%
OTC - PURPOSE SECTION
Anti-dandruff
Seborrheic Dermatitis treatment
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep Out of Reach of Children.
INACTIVE INGREDIENT SECTION
Inactive ingredients
ammonium laureth sulfate, ammonium lauryl sulfate, citric acid, cocamide DEA,
cocamidopropyl
betaine, DMDM hydantoin, isopropyl alcohol, menthol, titanium dioxide, water,
FD&C blue #2,
FD&C yellow #5