ESIKA MEN DANDRUFF MAXIMUM STRENGTH- pyrithione zinc shampoo

Esika Men Dandruff by

Drug Labeling and Warnings

Esika Men Dandruff by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients

Pyrithione zinc 0.528 percent

PURPOSE

Purpose

Antidandruff shampoo

INDICATIONS & USAGE

Uses

Reduces the symptoms of dandruff.

WARNINGS

Warnings

For external use only.

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

ASK DOCTOR

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

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.

DOSAGE & ADMINISTRATION

Directions

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

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

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.

INGREDIENTS AND APPEARANCE

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

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)