NDC Code(s) : 54565-3251-2, 54565-3251-1
Packager : Les Emballages Knowlton Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pit Boss Antiperspirant and Deodorant Aluminum Zirconium Tetrachlorohydrex Gly STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54565-3251
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 GLY25 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PPG-14 BUTYL ETHER(UNII: R199TJT95T)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
DIMETHICONE(UNII: 92RU3N3Y1O)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARETH-100(UNII: 4OH5W9UM87)
DOCOSANOL(UNII: 9G1OE216XY)
GLYCERIN(UNII: PDC6A3C0OX)
SUNFLOWER OIL(UNII: 3W1JG795YI)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54565-3251-278 g in 1 CANISTER Type 0: Not a Combination Product27/10/2017
2NDC:54565-3251-137 g in 1 CANISTER Type 0: Not a Combination Product27/10/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part350 10/27/2017

PRINCIPAL DISPLAY PANEL

Pit Boss Label