NDC Code(s) : 53897-000-01
Packager : Highland Consumer Products

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clinical Strength MiracleDry Antiperspirant Deodorant AMALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53897-000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY(UNII: P9D3YP29MY)
(ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY - UNII:P9D3YP29MY) 		ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY18 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PPG-11 STEARYL ETHER(UNII: S4G2J0Y0LG)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
STEARETH-2(UNII: V56DFE46J5)
STEARETH-20(UNII: L0Q8IK9E08)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
GLYCINE(UNII: TE7660XO1C)
STEARETH-21(UNII: 53J3F32P58)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53897-000-0150.3 mL in 1 BOTTLE Type 0: Not a Combination Product19/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M019 10/15/2012

LABELER - Highland Consumer Products(078647762)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc. 172198223 manufacture(53897-000)

PRINCIPAL DISPLAY PANEL

clinical strength   Miracle Dry  ANTIPERSPIRANT DEODORANT   AM  day formula    1.7 FL OZ   50.3 ML

PRINCIPAL DISPLAY PANEL

Miracle Dry AM