NDC Code(s) : 10889-421-01
Packager : VVF Kansas Services LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Melaleuca Alloy OriginalAluminum Zirconium Tetrachlorohydrex GLY STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10889-421
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY(UNII: 8O386558JE)
(ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY - UNII:8O386558JE) 		ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY19 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
BANCHA TEA LEAF/TWIG(UNII: EWI42IEH1C)
MELALEUCA ALTERNIFOLIA FLOWERING TOP(UNII: 5AZ4S6N66F)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
PPG-14 BUTYL ETHER(UNII: R199TJT95T)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
DIMETHICONE(UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES(UNII: 9S60Q72309)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10889-421-0164 g in 1 APPLICATOR Type 0: Not a Combination Product05/05/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part350 05/05/2016

PRINCIPAL DISPLAY PANEL

Alloy Original Labels