Label: CYZONE- pyrithione zinc liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-301-60, 13537-301-70 - Packager: VENTURA CORPORATION LTDA.,
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 10, 2010
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
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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).
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- PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label
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INGREDIENTS AND APPEARANCE
CYZONE TRAX COOLTURE DERMO COOL
pyrithione zinc liquidProduct 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)
