NDC Code(s) : 54473-405-01
Packager : Melaleuca, Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alloy ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY STICK
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-405
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 GLY10.24 g in 64 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
BAMBUSA ARUNDINACEA STEM(UNII: NRA4497HC5)
C15-19 ALKANE(UNII: CI87N1IM01)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
PARFUMIDINE(UNII: A2Q2LHC6MA)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)(UNII: N7YC58165T)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
BALANITES AEGYPTIACA SEED OIL(UNII: 75T177G59E)
DIHEPTYL SUCCINATE(UNII: 057N7SS26Y)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54473-405-0164 g in 1 APPLICATOR Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M019 05/01/2007

LABELER - Melaleuca, Inc(139760102)

Establishment
Name Address ID/FEI Business Operations
KDC/ONE Development Corporation, Inc 204006464 manufacture(54473-405)

PRINCIPAL DISPLAY PANEL

Alloy APDEO back.jpg

Alloy APDEO back.jpg