NDC | 13537-360-01 |
Set ID | ce073871-83e5-4af3-9639-d7f61f8df00b |
Category | HUMAN OTC DRUG LABEL |
Packager | Ventura Corporation (San Juan, P.R) |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART350 |
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
- Directions
- Inactive Ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 50 ML Bottle Label
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INGREDIENTS AND APPEARANCE
CYZONE BLUE AND BLUE FOR HIM
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-360 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aluminum Sesquichlorohydrate (UNII: UCN889409V) (Aluminum Sesquichlorohydrate - UNII:UCN889409V) Aluminum Sesquichlorohydrate 0.17 mL in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) STEARETH-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRICLOSAN (UNII: 4NM5039Y5X) CYCLOMETHICONE 6 (UNII: XHK3U310BA) EDETATE SODIUM (UNII: MP1J8420LU) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) LEVOMENOL (UNII: 24WE03BX2T) MAGNESIUM NITRATE (UNII: 77CBG3UN78) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-360-01 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part350 05/27/2011 Labeler - Ventura Corporation (San Juan, P.R) (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE