DERMAZINC- pyrithione zinc cream

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 0.25%

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children.

PURPOSE

Seborrheic Dermatitis treatment

DOSAGE & ADMINISTRATION

Apply to affected area twice daily or as directed by a doctor.

INDICATIONS & USAGE

For relief of the symptoms of seborrheic dermatitis.

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 aloe barbadensis leaf (aloe vera gel) juice, carbomer, cetyl
alcohol, dimethicone, DMDM hydantoin, glyceryl stearate, isopropyl palmitate, methylparaben,
mineral oil, PEG-75 lanolin, sodium 1auryl sulfate, stearic acid, tocopheryl acetate (vitamin E),
triethanolamine,undecylenic acid, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMAZINC 
pyrithione zinc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35324-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-75 LANOLIN (UNII: 09179OX7TB)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 980 (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE 200 (UNII: RGS4T2AS00)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPARABEN (UNII: A2I8C7HI9T)
DMDM HYDANTOIN (UNII: BYR0546TOW)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
TROLAMINE (UNII: 9O3K93S3TK)
UNDECYLENIC ACID (UNII: K3D86KJ24N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35324-001-04	114 g in 1 JAR; 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)