ESIKA  MEN MULTI-ACTION 2-IN-1- pyrithione zinc liquid 
Ventura Corporation (San Juan, P.R)

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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ēsika
MEN
2 en
1
shampoo
Multi-action

Drug Facts

Active Ingredients

Pyrithione Zinc (1.1 %)

Purpose

Antidandruff

Uses

Warnings

  • avoid contact with eyes. If contacts occurs, rinse eyes thoroughly with water.

  • if condition worsens or does not improve after regular use of this product as directed, consult a doctor (or physician).

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

Directions

Other information

Inactive ingredients

Aqua (water), sodium laureth sulfate, cocamidopropyl betaine, cocamide dea, dimethiconol, hydrolyzed soy protein, sodium chloride, hydrolyzed wheat protein, glycol distearate, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, guar hydroxypropyltrimonium chloride, parfum (fragrance), coco-glucoside, hydrolyzed rice protein, tea-dodecylbenzenesulfonate, propylene glycol, CI 77891 (titanium dioxide ), glyceryl oleate, glyceryl stearate, magnesium nitrate, zinc chloride, citric acid, butylene glycol, bambusa arundinacea leaf extract, CI 42090 (blue 1), panthenol, CI 19140 (yellow 5), methylchloroisothiazolinone, magnesium chloride, ppg-26-buteth-26, methylisothiazolinone, peg-40 hydrogenated castor oil, menthyl pca, menthol, dipropylene glycol , apigenin, CI 17200 (red 33), oleanolic acid, biotinoyl tripeptide-1.

PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label

MEN

2 en
1

shampoo

Multi-action

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

ēsika
300 ml e (10.1 fl.oz)

Principal Display Panel - 300 ml Bottle Label
ESIKA   MEN MULTI-ACTION 2-IN-1
pyrithione zinc liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-342
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc0.011 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
sodium laureth sulfate (UNII: BPV390UAP0)  
cocamidopropyl betaine (UNII: 5OCF3O11KX)  
coco diethanolamide (UNII: 92005F972D)  
sodium chloride (UNII: 451W47IQ8X)  
glycol distearate (UNII: 13W7MDN21W)  
trolamine (UNII: 9O3K93S3TK)  
coco glucoside (UNII: ICS790225B)  
tea-dodecylbenzenesulfonate (UNII: 8HM7ZD48HN)  
propylene glycol (UNII: 6DC9Q167V3)  
titanium dioxide (UNII: 15FIX9V2JP)  
glyceryl monooleate (UNII: 4PC054V79P)  
glyceryl monostearate (UNII: 230OU9XXE4)  
magnesium nitrate (UNII: 77CBG3UN78)  
zinc chloride (UNII: 86Q357L16B)  
citric acid monohydrate (UNII: 2968PHW8QP)  
butylene glycol (UNII: 3XUS85K0RA)  
bambusa arundinacea 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)  
methylisothiazolinone (UNII: 229D0E1QFA)  
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
menthol (UNII: L7T10EIP3A)  
dipropylene glycol (UNII: E107L85C40)  
d&c red no. 33 (UNII: 9DBA0SBB0L)  
oleanolic acid (UNII: 6SMK8R7TGJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-342-01300 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H05/17/2011
Labeler - Ventura Corporation (San Juan, P.R) (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE

Revised: 5/2011
Document Id: 8c2d556d-adaa-401b-a7cb-7fe07e96875f
Set id: 18ef4d2d-8f9a-48c9-8792-5f672c2584ef
Version: 1
Effective Time: 20110518
 
Ventura Corporation (San Juan, P.R)