Label: ESIKA FLOWERY ROLL-ON- aluminum sesquichlorohydrate liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 13537-063-01 - 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 December 13, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
-
INGREDIENTS AND APPEARANCE
ESIKA FLOWERY ROLL-ON
aluminum sesquichlorohydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-063 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 g 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) benzalkonium chloride (UNII: F5UM2KM3W7) edetate sodium (UNII: MP1J8420LU) levomenol (UNII: 24WE03BX2T) methylparaben (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-063-01 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part350 12/13/2011 Labeler - Ventura Corporation Ltd. (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-063)