DERMAZINC- pyrithione zinc shampoo

DermaZinc by

Drug Labeling and Warnings

DermaZinc by is a Otc medication manufactured, distributed, or labeled by WynnPharm Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Pyrithione Zinc 2%

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children.

PURPOSE

Anti-dandruff

Seborrheic Dermatitis treatment

DOSAGE & ADMINISTRATION

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.

INDICATIONS & USAGE

For relief of the symptoms of seborrheic dermatitis and dandruff.

WARNINGS

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.

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMAZINC 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35324-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
MENTHOL (UNII: L7T10EIP3A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35324-003-08	240 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	08/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	08/29/2022

Labeler - WynnPharm Inc (620885173)

Registrant - WynnPharm Inc (620885173)