CYZONE  TRAX COOLTURE DERMO COOL- pyrithione zinc liquid 
VENTURA CORPORATION LTDA.,

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Trax Coolture Antidandruff Shampoo

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.)

Principal Display Panel - 300 ml Bottle Label
CYZONE   TRAX COOLTURE DERMO COOL
pyrithione zinc liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione zinc (UNII: R953O2RHZ5) (Pyrithione zinc - UNII:R953O2RHZ5) Pyrithione zinc15 g  in 300 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-301-60300 mL in 1 BOTTLE
2NDC:13537-301-7010 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H08/15/2010
Labeler - VENTURA CORPORATION LTDA., (602751344)

Revised: 8/2010
Document Id: 240f3cbb-c4ce-4a40-9d08-4001f9893369
Set id: dd7d2343-39e6-47a5-91d7-cdfb7fa1c793
Version: 1
Effective Time: 20100810
 
VENTURA CORPORATION LTDA.,