Label: CYZONE BLUE AND BLUE FOR HIM- aluminum sesquichlorohydrate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-360-01 - Packager: Ventura Corporation (San Juan, P.R)
- 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 May 27, 2011
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- 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