ESIKA MEN DANDRUFF MAXIMUM STRENGTH- pyrithione zinc shampoo 
Ventura Corporation Limited

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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Esika Men Dandruff Shampoo Maximum Strength

Drug Facts

Active Ingredients

Pyrithione zinc 0.528 percent

Purpose

Antidandruff shampoo

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 conditions 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 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

shampoo MEN

Maximum Strength

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

ESIKA MEN DANDRUFF  MAXIMUM STRENGTH
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43596-0021
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC5.28 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0021-05 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/03/2012
Labeler - Ventura Corporation Limited (602751344)

Revised: 10/2012
Document Id: b2719932-5125-4491-8c56-1a6dac4039ef
Set id: 2a1ea593-995c-44b4-b0ad-9037b2020088
Version: 3
Effective Time: 20121003
 
Ventura Corporation Limited