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 (0.36%)

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

• 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, lauryl glucoside, coco-glucoside , glyceryl oleate, sodium chloride, hydrolyzed wheat protein, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, fragrance, guar hydroxypropyltrimonium chloride, glycol distearate, tea-dodecylbenzenesulfonate, tetrasodium edta, ci 77891 (titanium dioxide ), cocamide mea, laureth-10 , magnesium nitrate, citric acid, zinc chloride, butylene glycol, ci 19140 (yellow 5), methylchloroisothiazolinone , magnesium chloride, ppg-26-buteth-26, methylisothiazolinone, peg-40 hydrogenated castor oil, ci 42090 (blue 1), ci 14700 (red 4), apigenin, oleanolic acid, biotinoyl tripeptide-1.

PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label

MEN

shampoo
Effective Control
For all types of hair

> controls symptoms of dandruff
   with pyrithione zinc
> Strengthens debilitated hair

ēsika
300 ml e (10.1 fl.oz)

INGREDIENTS AND APPEARANCE

ESIKA   MEN EFFECTIVE CONTROL
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-341
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	0.0036 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)
lauryl glucoside (UNII: 76LN7P7UCU)
coco glucoside (UNII: ICS790225B)
glyceryl monooleate (UNII: 4PC054V79P)
sodium chloride (UNII: 451W47IQ8X)
trolamine (UNII: 9O3K93S3TK)
glycol distearate (UNII: 13W7MDN21W)
tea-dodecylbenzenesulfonate (UNII: 8HM7ZD48HN)
edetate sodium (UNII: MP1J8420LU)
titanium dioxide (UNII: 15FIX9V2JP)
coco monoethanolamide (UNII: C80684146D)
laureth-10 (UNII: BD7AST04GA)
magnesium nitrate (UNII: 77CBG3UN78)
citric acid monohydrate (UNII: 2968PHW8QP)
zinc chloride (UNII: 86Q357L16B)
butylene glycol (UNII: 3XUS85K0RA)
fd&c yellow no. 5 (UNII: I753WB2F1M)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
magnesium chloride (UNII: 02F3473H9O)
methylisothiazolinone (UNII: 229D0E1QFA)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
fd&c blue no. 1 (UNII: H3R47K3TBD)
fd&c red no. 4 (UNII: X3W0AM1JLX)
oleanolic acid (UNII: 6SMK8R7TGJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-341-01	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