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Cyzone

VENTURA CORPORATION LTDA.,

Trax Coolture Antidandruff Shampoo


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Pyrithione zinc 0.5%

Purpose

Antidandruff shampoo

Cyzone 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.)

Cyzone

Cyzone

Pyrithione zinc LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:13537-301
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PYRITHIONE ZINC 15 g

Inactive Ingredients

Ingredient Name Strength
water
SODIUM LAURETH SULFATE
Coco Diethanolamide
COCAMIDOPROPYL BETAINE
SODIUM CHLORIDE
GLYCOL DISTEARATE
TROLAMINE
CHLORIDE ION
CITRIC ACID MONOHYDRATE
GLYCERYL MONOSTEARATE
GLYCERYL MONOOLEATE
MAGNESIUM NITRATE
ZINC CHLORIDE
WHEAT
ALPHA-TOCOPHEROL ACETATE
PANTHENOL
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
MAGNESIUM CHLORIDE
MENTHOL
DIPROPYLENE GLYCOL
FD&C BLUE NO. 1
D&C RED NO. 33
FD&C YELLOW NO. 5

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partH part358H 2010-08-15


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