Label: CYZONE BE SEXY BS TECH ZINC PYRITHIONE AND SILICONES- pyrithione zinc lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-400-01 - Packager: Ventura Corporation Ltd.
- 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 November 29, 2011
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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- Directions
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Inactive ingredients
WATER, SODIUM LAURETH SULFATE, COCAMIDE DEA, COCAMIDOPROPYL BETAINE, DIMETHICONOL, SODIUM CHLORIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, FRAGRANCE, TRIETHANOLAMINE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, GLYCOL DISTEARATE, DICAPRYLYL CARBONATE, HYDROXYPROPYL METHYLCELLULOSE, COCO-GLUCOSIDE, TEA-DODECYLBENZENESULFONATE, CITRIC ACID, GLYCERYL STEARATE, GLYCERYL OLEATE, MAGNESIUM NITRATE, ZINC CHLORIDE, VACCINIUM MYRTILLUS FRUIT/LEAF EXTRACT, SACCHARUM OFFICINARUM EXTRACT (SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT), PEG-4 DISTEARYL ETHER, CI 42090 (BLUE 1), CITRUS AURANTIUM DULCIS FRUIT EXTRACT (CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT), CITRUS LIMON FRUIT EXTRACT (CITRUS LIMON(LEMON) FRUIT EXTRACT ), DISTEARYL ETHER, METHYLCHLOROISOTHIAZOLINONE, ACER SACCHARUM EXTRACT (ACER SACCHARUM (SUGAR MAPLE) EXTRACT), MAGNESIUM CHLORIDE, DYCAPRYLYL ETHER, METHYLISOTHIAZOLINONE, CI 17200 (RED 33)
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 375 ml Bottle Label
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INGREDIENTS AND APPEARANCE
CYZONE BE SEXY BS TECH ZINC PYRITHIONE AND SILICONES
pyrithione zinc lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc 0.0036 mg in 1 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) TROLAMINE (UNII: 9O3K93S3TK) GLYCOL DISTEARATE (UNII: 13W7MDN21W) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) COCO GLUCOSIDE (UNII: ICS790225B) TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERYL MONOOLEATE (UNII: 4PC054V79P) MAGNESIUM NITRATE (UNII: 77CBG3UN78) ZINC CHLORIDE (UNII: 86Q357L16B) VACCINIUM MYRTILLUS FRUITING TOP (UNII: QT6362QVN8) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ORANGE (UNII: 5EVU04N5QU) LEMON (UNII: 24RS0A988O) DISTEARYL ETHER (UNII: SC6T3MJF8Y) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-400-01 375 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 12/13/2011 Labeler - Ventura Corporation Ltd. (602751344) Establishment Name Address ID/FEI Business Operations Bel Star, S.A. 880160197 MANUFACTURE(13537-400)
