NDC Code(s) : 42283-031-50
Packager : AC Marca Personal Care

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LACTOVIT LACTOUREA DEODORANT AND ANTIPERSPIRANTALUMINUM CHLOROHYDRATE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42283-031
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALUMINUM CHLOROHYDRATE(UNII: HPN8MZW13M)
(ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M) 		ALUMINUM CHLOROHYDRATE63 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
STEARETH-2(UNII: V56DFE46J5)
PPG-15 STEARYL ETHER(UNII: 1II18XLS1L)
STEARETH-21(UNII: 53J3F32P58)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
HYDROXYETHYL UREA(UNII: MBQ7DDQ7AR)
SODIUM LACTATE(UNII: TU7HW0W0QT)
CALCIUM LACTATE(UNII: 2URQ2N32W3)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALLANTOIN(UNII: 344S277G0Z)
LEVOMENOL(UNII: 24WE03BX2T)
TRICLOSAN(UNII: 4NM5039Y5X)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
FARNESOL(UNII: EB41QIU6JL)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ISOMETHYL-.ALPHA.-IONONE(UNII: 9XP4LC555B)
CITRAL(UNII: T7EU0O9VPP)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
COUMARIN(UNII: A4VZ22K1WT)
GERANIOL(UNII: L837108USY)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42283-031-5050 mL in 1 BOTTLE Type 0: Not a Combination Product23/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part350 01/23/2018

PRINCIPAL DISPLAY PANEL

LACTOVIT LACTOUREA DEODORANT AND ANTIPERSPIRANT