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 Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0021
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 5.28 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
SOY PROTEIN (UNII: R44IWB3RN5)  
COCO GLUCOSIDE (UNII: ICS790225B)  
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
PANTHENOL (UNII: WV9CM0O67Z)  
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- (UNII: 8P18J856U2)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
MENTHA AQUATICA LEAF (UNII: 5M106ME6PT)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
MENTHOL (UNII: L7T10EIP3A)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
APIGENIN (UNII: 7V515PI7F6)  
BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
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)

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