ESIKA- pyrithione zinc liquid

ESIKA by

Drug Labeling and Warnings

ESIKA by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation (San Juan, P.R), Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Pyrithione Zinc (1.1 %)

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

• Apply shampoo to wet hair. Massage until foaming. Rinse with water to remove all hair shampoo. Repeat if necessary.
• 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, sodium chloride, hydrolyzed wheat protein, glycol distearate, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, guar hydroxypropyltrimonium chloride, parfum (fragrance), coco-glucoside, hydrolyzed rice protein, tea-dodecylbenzenesulfonate, propylene glycol, CI 77891 (titanium dioxide ), glyceryl oleate, glyceryl stearate, magnesium nitrate, zinc chloride, citric acid, butylene glycol, bambusa arundinacea leaf extract, CI 42090 (blue 1), panthenol, CI 19140 (yellow 5), methylchloroisothiazolinone, magnesium chloride, ppg-26-buteth-26, methylisothiazolinone, peg-40 hydrogenated castor oil, menthyl pca, menthol, dipropylene glycol , apigenin, CI 17200 (red 33), oleanolic acid, biotinoyl tripeptide-1.

PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label

MEN

2 en
1

shampoo

Multi-action

> maximum brilliance and softness
> controls symptoms of dandruff
   with pyrithione zinc
> hair can be combed more easily

ēsika
300 ml e (10.1 fl.oz)

INGREDIENTS AND APPEARANCE

ESIKA   MEN MULTI-ACTION 2-IN-1
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-342
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	0.011 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
sodium laureth sulfate (UNII: BPV390UAP0)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
coco diethanolamide (UNII: 92005F972D)
sodium chloride (UNII: 451W47IQ8X)
glycol distearate (UNII: 13W7MDN21W)
trolamine (UNII: 9O3K93S3TK)
coco glucoside (UNII: ICS790225B)
tea-dodecylbenzenesulfonate (UNII: 8HM7ZD48HN)
propylene glycol (UNII: 6DC9Q167V3)
titanium dioxide (UNII: 15FIX9V2JP)
glyceryl monooleate (UNII: 4PC054V79P)
glyceryl monostearate (UNII: 230OU9XXE4)
magnesium nitrate (UNII: 77CBG3UN78)
zinc chloride (UNII: 86Q357L16B)
citric acid monohydrate (UNII: 2968PHW8QP)
butylene glycol (UNII: 3XUS85K0RA)
bambusa arundinacea leaf (UNII: HW86D1FGSS)
fd&c blue no. 1 (UNII: H3R47K3TBD)
panthenol (UNII: WV9CM0O67Z)
fd&c yellow no. 5 (UNII: I753WB2F1M)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
magnesium chloride (UNII: 02F3473H9O)
methylisothiazolinone (UNII: 229D0E1QFA)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
menthol (UNII: L7T10EIP3A)
dipropylene glycol (UNII: E107L85C40)
d&c red no. 33 (UNII: 9DBA0SBB0L)
oleanolic acid (UNII: 6SMK8R7TGJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-342-01	300 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	05/17/2011

Labeler - Ventura Corporation (San Juan, P.R) (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE