ESIKA MEN 2 EN 1 ANTIDANDRUFF MULTI-ACTION- pyrithione zinc liquid

ESIKA MEN 2 EN 1 ANTIDANDRUFF MULTI-ACTION by

Drug Labeling and Warnings

ESIKA MEN 2 EN 1 ANTIDANDRUFF MULTI-ACTION by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

PYRITHIONE ZINC 0.5%

Purpose

Antidandruff

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, HYDROLYZED SOY PROTEIN, SODIUM CHLORIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, GLYCOL DISTEARATE, TRIETHANOLAMINE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, FRAGRANCE, COCO-GLUCOSIDE, HYDROLYZED RICE PROTEIN, TEA-DODECYLBENZENESULFONATE,HYDROLYZED WHEAT PROTEIN, CITRIC ACID, PROPYLENE GLYCOL, TITANIUM DIOXIDE, GLYCERYL OLEATE, GLYCERYL STEARATE, MAGNESIUM NITRATE, ZINC CHLORIDE, BUTYLENE GLYCOL, BAMBUSA ARUNDINACEA LEAF EXTRACT, BLUE 1, PANTHENOL, YELLOW 5, METHYLCHLOROISOTHIAZOLINONE, MAGNESIUM CHLORIDE, PPG-26-BUTETH-26, METHYLISOTHIAZOLINONE, PEG-40 HYDROGENATED CASTOR OIL, MENTHYL PCA, MENTHOL, DIPROPYLENE GLYCOL, APIGENIN, RED 33, OLEANOLIC ACID, BIOTINOYL TRIPEPTIDE-1, HEXYL CINNAMAL, LINALOOL, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label

MEN

2en
1

antidandruff shampoo

Multi-action

• > maximum brilliance and softness
• > controls symptoms of dandruff
  with pyrithione zinc
• > hair can be combed more easily

ésika

300 ml e (10.1 fl.oz.)

INGREDIENTS AND APPEARANCE

ESIKA MEN 2 EN 1 ANTIDANDRUFF MULTI-ACTION 
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-751
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
TROLAMINE (UNII: 9O3K93S3TK)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
COCO GLUCOSIDE (UNII: ICS790225B)
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL OLEATE (UNII: 4PC054V79P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
ZINC CHLORIDE (UNII: 86Q357L16B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BAMBUSA BAMBOS LEAF (UNII: HW86D1FGSS)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PANTHENOL (UNII: WV9CM0O67Z)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
MENTHYL DL-PYRROLIDONECARBOXYLATE (UNII: 8P18J856U2)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
APIGENIN (UNII: 7V515PI7F6)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-751-01	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/17/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/17/2015

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-751)