Label: ESIKA- 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 May 18, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Pyrithione Zinc (1.1 %)

  • Purpose

    Antidandruff

  • Uses

    • Helps stop irritation and flaking associated with dandruff.
  • Warnings

    • for external use only.

    • 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

    • Apply shampoo to wet hair. Massage until foaming. Rinse with water to remove all hair shampoo. Repeat if necessary.
    • For best results, use at least 2 times a week or as directed by a doctor (or physician).
  • Other information

    • Ask a doctor before use if you have seborrheic dermatitis that covers a large area of the body.
  • 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
  • INGREDIENTS AND APPEARANCE
    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
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