CYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]

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CYZONE (PYRITHIONE ZINC) LIQUID [VENTURA CORPORATION LTDA.,]
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NDC 13537-301-60, 13537-301-70
Set ID dd7d2343-39e6-47a5-91d7-cdfb7fa1c793
Category HUMAN OTC DRUG LABEL
Packager VENTURA CORPORATION LTDA.,
Generic Name
Product Class
Product Number
Application Number PART358H
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  • 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.)

    Principal Display Panel - 300 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    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)
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