Drug Facts

Active Ingredient

ZINC PYRITHIONE 0.528 %

Purpose

Antidandruff shampoo

Uses

Reduces the symptoms of dandruff

Warnings

For external use only

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

If condition worsens or does not improve after regular use of this product as directed, consult a doctor

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For best results use at least twice a week or as directed by a doctor.

Inactive ingredients

WATER, SODIUM LAURETH SULFATE, COCAMIDE DEA, COCAMIDOPROPYL BETAINE, DIMETHICONOL, GLYCOL DISTEARATE, HYDROLYZED SOY PROTEIN, SODIUM CHLORIDE, FRAGRANCE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, COCO-GLUCOSIDE, HYDROLYZED WHEAT PROTEIN, TEA-DODECYLBENZENESULFONATE, GLYCERYL OLEATE, GLYCERYL STEARATE, CI 77891 (TITANIUM DIOXIDE ), MAGNESIUM NITRATE, CITRIC ACID, HYDROLYZED RICE PROTEIN, ZINC CHLORIDE, BUTYLENE GLYCOL, CI 19140 (YELLOW 5), PANTHENOL, HYDROLYZED CORN PROTEIN, MENTHYL PCA, METHYLCHLOROISOTHIAZOLINONE, MENTHA AQUATICA LEAF EXTRACT, PROPYLENE GLYCOL, MAGNESIUM CHLORIDE, SACCHAROMYCES/MAGNESIUM FERMENT, CI 14700 (RED 4), PPG-26-BUTETH-26, METHYLISOTHIAZOLINONE, PEG-40 HYDROGENATED CASTOR OIL, MENTHOL, DIPROPYLENE GLYCOL, SACCHAROMYCES/IRON FERMENT, SACCHAROMYCES/COPPER FERMENT, SACCHAROMYCES/SILICON FERMENT, SACCHAROMYCES/ZINC FERMENT, CI 42090 (BLUE 1), APIGENIN, BIOTINOYL TRIPEPTIDE-1, OLEANOLIC ACID

Puerto Rico: Distribuited by Ventura Corporation Ltd., San Juan, Puerto Rico 00924.

PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label

MEN

shampoo

Maximum Strength

>: Nourishes* and moisturizes hair
>: Prevents dandruff
>: Provides maximum cleaning
*due to strengthening

ésika
300 ml e (10.1 fl.oz)

Principal Display Panel - 300 ml Bottle Label

ESIKA MEN MAXIMUM STRENGTH
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-449
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.00528 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TROLAMINE (UNII: 9O3K93S3TK)
COCO GLUCOSIDE (UNII: ICS790225B)
TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ZINC CHLORIDE (UNII: 86Q357L16B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PANTHENOL (UNII: WV9CM0O67Z)
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- (UNII: 8P18J856U2)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
MENTHA AQUATICA LEAF (UNII: 5M106ME6PT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
MENTHOL (UNII: L7T10EIP3A)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
APIGENIN (UNII: 7V515PI7F6)
BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-449-01	300 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part358H	01/24/2012

Labeler - Ventura International Ltd (603192787)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE