Label: CYZONE XPRESS YOUR BODY CLARITY- aluminum sesquichlorohydrate emulsion
-
Contains inactivated NDC Code(s)
NDC Code(s): 13537-989-01 - 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 August 9, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Ingredientes activos
- Propósito
- Uso
- Advertencias
- Instrucciones
-
Ingredientes inactivo
WATER, STEARETH-2, STEARETH-21, PPG-15 STEARYL ETHER, CYCLOPENTASILOXANE, PROPYLENE GLYCOL, CYCLOHEXASILOXANE, FRAGRANCE, SODIUM LACTATE, DICAPRYLYL CARBONATE, BUTYLENE GLYCOL, TRICLOSAN, ARCTOSTAPHYLOS UVA URSI LEAF EXTRACT, METHYLPARABEN, BISABOLOL, BENZALKONIUM CHLORIDE, BHT, SILK, GLYCERIN, TETRASODIUM EDTA, ROSA GALLICA FLOWER EXTRACT, ALCOHOL, LINALOOL, BENZYL SALICYLATE, GERANIOL, CITRONELLOL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, ALPHA-ISOMETHYL IONONE, HYDROXYCITRONELLAL.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
-
INGREDIENTS AND APPEARANCE
CYZONE XPRESS YOUR BODY CLARITY
aluminum sesquichlorohydrate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-989 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 0.16 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) STEARETH-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) PPG-15 STEARYL ETHER (UNII: 1II18XLS1L) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SODIUM LACTATE (UNII: TU7HW0W0QT) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRICLOSAN (UNII: 4NM5039Y5X) ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36) METHYLPARABEN (UNII: A2I8C7HI9T) LEVOMENOL (UNII: 24WE03BX2T) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BOMBYX MORI FIBER (UNII: 6LK42KUV6W) GLYCERIN (UNII: PDC6A3C0OX) EDETATE SODIUM (UNII: MP1J8420LU) ROSA GALLICA FLOWER (UNII: X8W61WUV70) ALCOHOL (UNII: 3K9958V90M) LINALOOL, (+/-)- (UNII: D81QY6I88E) BENZYL SALICYLATE (UNII: WAO5MNK9TU) GERANIOL (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-989-01 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/09/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part350 08/09/2016 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-989)