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

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Pyrithione Zinc (0.36%)

  • 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

    • 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, lauryl glucoside, coco-glucoside , glyceryl oleate, sodium chloride, hydrolyzed wheat protein, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, fragrance, guar hydroxypropyltrimonium chloride, glycol distearate, tea-dodecylbenzenesulfonate, tetrasodium edta, ci 77891 (titanium dioxide ), cocamide mea, laureth-10 , magnesium nitrate, citric acid, zinc chloride, butylene glycol, ci 19140 (yellow 5), methylchloroisothiazolinone , magnesium chloride, ppg-26-buteth-26, methylisothiazolinone, peg-40 hydrogenated castor oil, ci 42090 (blue 1), ci 14700 (red 4), apigenin, oleanolic acid, biotinoyl tripeptide-1.

  • PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label

    MEN

    shampoo
    Effective Control
    For all types of hair

    > controls symptoms of dandruff
       with pyrithione zinc
    > Strengthens debilitated hair

    ēsika
    300 ml e (10.1 fl.oz)

    PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ESIKA   MEN EFFECTIVE CONTROL
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-341
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc0.0036 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    sodium laureth sulfate (UNII: BPV390UAP0)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    coco diethanolamide (UNII: 92005F972D)  
    lauryl glucoside (UNII: 76LN7P7UCU)  
    coco glucoside (UNII: ICS790225B)  
    glyceryl monooleate (UNII: 4PC054V79P)  
    sodium chloride (UNII: 451W47IQ8X)  
    trolamine (UNII: 9O3K93S3TK)  
    glycol distearate (UNII: 13W7MDN21W)  
    tea-dodecylbenzenesulfonate (UNII: 8HM7ZD48HN)  
    edetate sodium (UNII: MP1J8420LU)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    coco monoethanolamide (UNII: C80684146D)  
    laureth-10 (UNII: BD7AST04GA)  
    magnesium nitrate (UNII: 77CBG3UN78)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    zinc chloride (UNII: 86Q357L16B)  
    butylene glycol (UNII: 3XUS85K0RA)  
    fd&c yellow no. 5 (UNII: I753WB2F1M)  
    methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    magnesium chloride (UNII: 02F3473H9O)  
    methylisothiazolinone (UNII: 229D0E1QFA)  
    polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    fd&c red no. 4 (UNII: X3W0AM1JLX)  
    oleanolic acid (UNII: 6SMK8R7TGJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-341-01300 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
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!