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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 17, 2016

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  • 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.)

    PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    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)
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