NDC | 13537-963-01 |
Set ID | de764e5b-d117-44ac-9d84-233ac2d01526 |
Category | HUMAN OTC DRUG LABEL |
Packager | Ventura Corporation LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART350 |
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
WATER, STEARETH-2, PPG-15 STEARYL ETHER, STEARETH-21, FRAGRANCE, DICAPRYLYL CARBONATE, CYCLOPENTASILOXANE, BENZYL ALCOHOL, TRICLOSAN, CYCLOHEXASILOXANE, TETRASODIUM EDTA, BISABOLOL, LINALOOL, d-LIMONENE, HEXYL CINNAMAL, BENZYL SALICYLATE, BUTYLPHENYL METHYLPROPIONAL, COUMARIN, CITRONELLOL, EUGENOL, CITRAL, ALPHA-ISOMETHYL IONONE, GERANIOL.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
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INGREDIENTS AND APPEARANCE
CYZONE NITRO DESODORANTE ANTITRANSPIRANTE ROLL-ON FM
aluminum sesquichlorohydrate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-963 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE 0.136 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) STEARETH-2 (UNII: V56DFE46J5) PPG-15 STEARYL ETHER (UNII: 1II18XLS1L) STEARETH-21 (UNII: 53J3F32P58) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BENZYL ALCOHOL (UNII: LKG8494WBH) TRICLOSAN (UNII: 4NM5039Y5X) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE SODIUM (UNII: MP1J8420LU) LEVOMENOL (UNII: 24WE03BX2T) LINALOOL, (+/-)- (UNII: D81QY6I88E) LIMONENE, (+)- (UNII: GFD7C86Q1W) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) COUMARIN (UNII: A4VZ22K1WT) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) EUGENOL (UNII: 3T8H1794QW) CITRAL (UNII: T7EU0O9VPP) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) GERANIOL (UNII: L837108USY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-963-01 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part350 07/11/2016 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-963)