NDC Code(s) : 59088-740-05
Packager : PureTek Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Body Essence Raspberry Antibacterial Triclosan LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-740
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN(UNII: 4NM5039Y5X)
(TRICLOSAN - UNII:4NM5039Y5X) 		TRICLOSAN1.7 uL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUNFLOWER OIL(UNII: 3W1JG795YI)
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
MENTHYL LACTATE(UNII: 2BF9E65L7I)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
PANTHENOL(UNII: WV9CM0O67Z)
CAMELLIA OLEIFERA SEED(UNII: 59ED29FM2J)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
WHEAT GERM OIL(UNII: 14C97E680P)
LACTOSE(UNII: J2B2A4N98G)
LAURETH-7(UNII: Z95S6G8201)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYOXYL 100 STEARATE(UNII: YD01N1999R)
CETYL PHOSPHATE(UNII: VT07D6X67O)
HYPROMELLOSES(UNII: 3NXW29V3WO)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
CARBOMER HOMOPOLYMER TYPE A(UNII: F68VH75CJC)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
TROLAMINE(UNII: 9O3K93S3TK)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
ETHYLPARABEN(UNII: 14255EXE39)
ISOBUTYLPARABEN(UNII: 0QQJ25X58G)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
FD&C RED NO. 4(UNII: X3W0AM1JLX)
XANTHAN GUM(UNII: TTV12P4NEE)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59088-740-0559 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 12/28/2009

PRINCIPAL DISPLAY PANEL

image of label