Label: ESIKA MEN DANDRUFF MAXIMUM STRENGTH- pyrithione zinc shampoo

  • NDC Code(s): 43596-0021-0
  • Packager: Ventura Corporation Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active Ingredients

    Pyrithione zinc 0.528 percent

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  • PURPOSE

    Purpose

    Antidandruff shampoo

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  • INDICATIONS & USAGE

    Uses

    Reduces the symptoms of dandruff.

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  • WARNINGS

    Warnings

    For external use only.

    Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

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  • ASK DOCTOR

    If conditions worsens or does not improve after regular use of this product as directed, consult a doctor.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • DOSAGE & ADMINISTRATION

    Directions

    For best results use at least twice a week or as directed by a doctor.

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  • INACTIVE INGREDIENT

    Inactive ingredients Aqua (Water), Sodium Laureth Sulfate, Cocamide Dea, Cocamidopropyl Betaine, Dimethiconol, Glycol Distearate, Hydrolyzed Soy Protein, Sodium Chloride, Parfum (Fragrance), Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Guar Hydroxypropyltrimonium Chloride, Coco-glucoside, Hydrolyzed Wheat Protein, Tea-dodecylbenzenesulfonate, Glyceryl Oleate, Glyceryl Stearate, Ci 77891 (Titanium Dioxide ), Magnesium Nitrate, Citric Acid, Hydrolyzed Rice Protein, Zinc Chloride, Butylene Glycol, Ci 19140 (Yellow 5), Panthenol, Hydrolyzed Corn Protein, Menthyl Pca, Methylchloroisothiazolinone, Mentha Aquatica Leaf Extract, Propylene Glycol, Magnesium Chloride, Saccharomyces/magnesium Ferment, Ci 14700 (Red 4), Ppg-26-buteth-26, Methylisothiazolinone, Peg-40 Hydrogenated Castor Oil, Menthol, Dipropylene Glycol, Saccharomyces/iron Ferment, Saccharomyces/copper Ferment, Saccharomyces/silicon Ferment, Saccharomyces/zinc Ferment, Ci 42090 (Blue 1), Apigenin, Biotinoyl Tripeptide-1, Oleanolic Acid

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  • PRINCIPAL DISPLAY PANEL

    shampoo MEN

    Maximum Strength

    • Nourishes hair asterisk
    • Hydrates effectively
    • Provides maximum cleaning
    asterisk due to strengthens

    esika

    5ml e (0.16 fl.oz)

    P.R.: Dist. by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926. Made in Colombia.

    front panel

    back panel

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  • INGREDIENTS AND APPEARANCE
    ESIKA MEN DANDRUFF  MAXIMUM STRENGTH
    pyrithione zinc shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:43596-0021
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC 5.28 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURETH SULFATE  
    COCO DIETHANOLAMIDE  
    COCAMIDOPROPYL BETAINE  
    GLYCOL DISTEARATE  
    SOY PROTEIN  
    COCO GLUCOSIDE  
    TRIETHANOLAMINE DODECYLBENZENESULFONATE  
    GLYCERYL OLEATE  
    GLYCERYL MONOSTEARATE  
    TITANIUM DIOXIDE  
    MAGNESIUM NITRATE  
    CITRIC ACID MONOHYDRATE  
    ZINC CHLORIDE  
    BUTYLENE GLYCOL  
    FD&C YELLOW NO. 5  
    PANTHENOL  
    MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL-  
    METHYLCHLOROISOTHIAZOLINONE  
    MENTHA AQUATICA LEAF  
    PROPYLENE GLYCOL  
    MAGNESIUM CHLORIDE  
    FD&C RED NO. 4  
    METHYLISOTHIAZOLINONE  
    POLYOXYL 40 CASTOR OIL  
    MENTHOL  
    DIPROPYLENE GLYCOL  
    FD&C BLUE NO. 1  
    APIGENIN  
    BIOTINOYL TRIPEPTIDE-1  
    OLEANOLIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43596-0021-0 5 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 10/03/2012
    Labeler - Ventura Corporation Limited (602751344)
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