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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ÉSIKA MEN 2 EN 1 ANTIDANDRUFF SHAMPOO MULTI-ACTION

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.

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.)

PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label
ESIKA MEN 2 EN 1 ANTIDANDRUFF MULTI-ACTION 
pyrithione zinc liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-751
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc0.05 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-751-01300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/17/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/17/2015
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-751)

Revised: 8/2016
Document Id: 0500d778-7a1b-472b-8171-a6230814c9d6
Set id: fcc5613f-fbc0-4e6b-970d-90a37bde21e1
Version: 1
Effective Time: 20160817
 
Ventura Corporation LTD