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 (0.34%)

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, dimethicone, cocamide mipa, cetyl alcohol, sodium chloride, glycol distearate, parfum (fragrance), polyquaternium-7, guar hydroxypropyltrimonium chloride, citric acid, magnesium nitrate, aloe barbadensis leaf juice, hydrolyzed soy protein, hydrolyzed wheat protein, soluble collagen, zinc chloride, zinc pca, methylchloroisothiazolinone, magnesium chloride, methylisothiazolinone.

PRINCIPAL DISPLAY PANEL - 400 ml Bottle Label

Vital
WITH ACTIVE-Z

2 in 1

DANDRUFF CONTROL

SHAMPOO +
HAIR CONDITIONER

FOR CONTROLLING DANDRUFF WITH
PYRITHIONE ZINC

ēsika

400 ml e ( 13.5 fl.oz.)

INGREDIENTS AND APPEARANCE

ESIKA   VITAL WITH ACTIVE Z 2-IN-1 DANDRUFF CONTROL
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-353
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	0.0034 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
sodium laureth sulfate (UNII: BPV390UAP0)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
dimethicone (UNII: 92RU3N3Y1O)
cetyl alcohol (UNII: 936JST6JCN)
sodium chloride (UNII: 451W47IQ8X)
glycol distearate (UNII: 13W7MDN21W)
citric acid monohydrate (UNII: 2968PHW8QP)
magnesium nitrate (UNII: 77CBG3UN78)
aloe vera leaf (UNII: ZY81Z83H0X)
zinc chloride (UNII: 86Q357L16B)
zinc pidolate (UNII: C32PQ86DH4)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
magnesium chloride (UNII: 02F3473H9O)
methylisothiazolinone (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-353-01	400 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