CYZONE- pyrithione zinc liquid

Cyzone by

Drug Labeling and Warnings

Cyzone by is a Otc medication manufactured, distributed, or labeled by VENTURA CORPORATION LTDA.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Pyrithione zinc 0.5%

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 condition 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, sodium chloride, parfum (fragrance), acrylates/c10-30 alkyl acrylate crosspolymer, glycol distearate, triethanolamine, guar hydroxypropyltrimonium chloride, coco-glucoside, tea-dodecylbenzenesulfonate, citric acid, , glyceryl stearate, , glyceryl oleate, magnesium nitrate, zinc chloride, hydrolyzed wheat protein, tocopheryl acetate, panthenol, menthyl pca, methylchloroisothiazolinone, magnesium chloride, methylisothiazolinone, menthol, dipropylene glycol, saccharomyces/sea salt ferment, ci 42090 (blue 1), ci 17200 (red 33), ci 19140 (yellow 5).

Questions?

Puerto Rico: 622-3235 (San José)

PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label

SHAMPOO 2 EN 1
CONTROL CASPA

trax
coolture

DERMO COOL

cy°zone

300 ml e
(10.1 fl.oz.)

INGREDIENTS AND APPEARANCE

CYZONE   TRAX COOLTURE DERMO COOL
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione zinc (UNII: R953O2RHZ5) (Pyrithione zinc - UNII:R953O2RHZ5)	Pyrithione zinc	15 g  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
sodium laureth sulfate (UNII: BPV390UAP0)
coco diethanolamide (UNII: 92005F972D)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
sodium chloride (UNII: 451W47IQ8X)
glycol distearate (UNII: 13W7MDN21W)
trolamine (UNII: 9O3K93S3TK)
chloride ion (UNII: Q32ZN48698)
citric acid monohydrate (UNII: 2968PHW8QP)
glyceryl monostearate (UNII: 230OU9XXE4)
glyceryl monooleate (UNII: 4PC054V79P)
magnesium nitrate (UNII: 77CBG3UN78)
zinc chloride (UNII: 86Q357L16B)
wheat (UNII: 4J2I0SN84Y)
alpha-tocopherol acetate (UNII: 9E8X80D2L0)
panthenol (UNII: WV9CM0O67Z)
methylchloroisothiazolinone (UNII: DEL7T5QRPN)
methylisothiazolinone (UNII: 229D0E1QFA)
magnesium chloride (UNII: 02F3473H9O)
menthol (UNII: L7T10EIP3A)
dipropylene glycol (UNII: E107L85C40)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-301-60	300 mL in 1 BOTTLE
2	NDC: 13537-301-70	10 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	08/15/2010

Labeler - VENTURA CORPORATION LTDA., (602751344)