NDC Code(s) : 42283-021-00
Packager : Laboratorios Genesse SL

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lactovit DEO ROLL-ON LACTOUREA DEODORANT ANTIPERSPIRANTALUMINUM CHLOROHYDRATE, ALUMINUM SESQUICHLOROHYDRATE LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42283-021
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 CHLOROHYDRATE6.4 mg in 1 mL
ALUMINUM SESQUICHLOROHYDRATE(UNII: UCN889409V)
(ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) 		ALUMINUM SESQUICHLOROHYDRATE0.6464 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)0.000001 mL in 1 mL
STEARETH-2(UNII: V56DFE46J5)3 mL in 1 mL
PPG-15 STEARYL ETHER(UNII: 1II18XLS1L)2 mL in 1 mL
STEARETH-21(UNII: 53J3F32P58)1.5 mL in 1 mL
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)0.8 mL in 1 mL
HYDROXYETHYL UREA(UNII: MBQ7DDQ7AR)0.4 mL in 1 mL
SODIUM LACTATE(UNII: TU7HW0W0QT)0.00013 mg in 1 mL
CASEIN(UNII: 48268V50D5)0.019 mL in 1 mL
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)0.2 mL in 1 mL
ALLANTOIN(UNII: 344S277G0Z)0.1 mL in 1 mL
CHITOSAN PCA(UNII: 6X7Y81JM3P)0.03856 mL in 1 mL
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)0.5 mL in 1 mL
FARNESOL(UNII: EB41QIU6JL)3 mL in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.2 mL in 1 mL
PHENOXYETHANOL(UNII: HIE492ZZ3T)0.0004 mL in 1 mL
ISOMETHYL-.ALPHA.-IONONE(UNII: 9XP4LC555B)0.0178 mL in 1 mL
BUTYLPHENYL METHYLPROPIONAL(UNII: T7540GJV69)0.0392 mL in 1 mL
CITRAL(UNII: T7EU0O9VPP)0.0046 mL in 1 mL
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)0.0145 mL in 1 mL
COUMARIN(UNII: A4VZ22K1WT)0.0135 mL in 1 mL
LIMONENE, (+)-(UNII: GFD7C86Q1W)0.0384 mL in 1 mL
GERANIOL(UNII: L837108USY)0.0128 mL in 1 mL
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)0.0405 mL in 1 mL
.ALPHA.-BISABOLOL, (+)-(UNII: 105S6I733Z)0.097 mL in 1 mL
SODIUM ALGINATE(UNII: C269C4G2ZQ)0.00816 mL in 1 mL
GLYCINE(UNII: TE7660XO1C)0.0002 mL in 1 mL
PVP/VA COPOLYMER(UNII: D9C330MD8B)0.3 mL in 1 mL
AMMONIUM LACTATE(UNII: 67M901L9NQ)0.2 mL in 1 mL
PERFLUNAFENE(UNII: 54A06VV62N)1.1676 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42283-021-0050 mL in 1 BOTTLE Type 0: Not a Combination Product19/11/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part350 11/19/2016

PRINCIPAL DISPLAY PANEL

Lactovit DEO ROLL-ON LACTOUREA DEODORANT ANTIPERSPIRANT

BOTTLE