ESIKA  VITAL WITH ACTIVE Z 2-IN-1 DANDRUFF CONTROL- 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
Vital
WITH ACTIVE-Z
2 in 1
DANDRUFF CONTROL
SHAMPOO +
HAIR CONDITIONER

Drug Facts

Active Ingredients

Pyrithione Zinc (0.34%)

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, dimethicone, cocamide mipa, cetyl alcohol, sodium chloride, glycol distearate, parfum (fragrance), polyquaternium-7, guar hydroxypropyltrimonium chloride, citric acid, magnesium nitrate, aloe barbadensis leaf juice, hydrolyzed soy protein, hydrolyzed wheat protein, soluble collagen, zinc chloride, zinc pca, methylchloroisothiazolinone, magnesium chloride, methylisothiazolinone.

PRINCIPAL DISPLAY PANEL - 400 ml Bottle Label

Vital
WITH ACTIVE-Z

2 in 1

DANDRUFF CONTROL

SHAMPOO +
HAIR CONDITIONER

FOR CONTROLLING DANDRUFF WITH
PYRITHIONE ZINC

ēsika

400 ml e ( 13.5 fl.oz.)

Principal Display Panel - 400 ml Bottle Label
ESIKA   VITAL WITH ACTIVE Z 2-IN-1 DANDRUFF CONTROL
pyrithione zinc liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-353
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc0.0034 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
sodium laureth sulfate (UNII: BPV390UAP0)  
cocamidopropyl betaine (UNII: 5OCF3O11KX)  
dimethicone (UNII: 92RU3N3Y1O)  
cetyl alcohol (UNII: 936JST6JCN)  
sodium chloride (UNII: 451W47IQ8X)  
glycol distearate (UNII: 13W7MDN21W)  
citric acid monohydrate (UNII: 2968PHW8QP)  
magnesium nitrate (UNII: 77CBG3UN78)  
aloe vera leaf (UNII: ZY81Z83H0X)  
zinc chloride (UNII: 86Q357L16B)  
zinc pidolate (UNII: C32PQ86DH4)  
methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
magnesium chloride (UNII: 02F3473H9O)  
methylisothiazolinone (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-353-01400 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: 0ec8a72b-c0ca-4210-ac5d-14139563b670
Set id: db0c1d37-984f-4316-8e27-551891152a8d
Version: 1
Effective Time: 20110518
 
Ventura Corporation (San Juan, P.R)