NDC Code(s) : 66184-152-01, 66184-152-02
Packager : Coty US LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sally Hansen Cracked Heel Repair Creme Dimethicone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66184-152
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE1.133 g in 113 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
MINERAL OIL(UNII: T5L8T28FGP)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES(UNII: 9S60Q72309)
PETROLATUM(UNII: 4T6H12BN9U)
PALMITIC ACID(UNII: 2V16EO95H1)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLYCERIN(UNII: PDC6A3C0OX)
CETYL ALCOHOL(UNII: 936JST6JCN)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
SHEANUT OIL(UNII: O88E196QRF)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
METHYLPARABEN(UNII: A2I8C7HI9T)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALLANTOIN(UNII: 344S277G0Z)
UREA(UNII: 8W8T17847W)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
MYRISTIC ACID(UNII: 0I3V7S25AW)
LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE(UNII: 7461U1YLB7)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
ETHYLPARABEN(UNII: 14255EXE39)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)(UNII: ZR28QKN0WT)
MAGNESIUM ASCORBYL PHOSPHATE(UNII: 0R822556M5)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
SOYBEAN(UNII: L7HT8F1ZOD)
SODIUM SULFATE(UNII: 0YPR65R21J)
CERAMIDE 2(UNII: C04977SRJ5)
PEG-10 RAPESEED STEROL(UNII: 258O76T85M)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
BENZOIC ACID(UNII: 8SKN0B0MIM)
SODIUM BENZOATE(UNII: OJ245FE5EU)
TOCOPHEROL(UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
PALMITOYL OLIGOPEPTIDE(UNII: HO4ZT5S86C)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
SHEA BUTTER(UNII: K49155WL9Y)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
Citral(UNII: T7EU0O9VPP)
CERAMIDE 2(UNII: C04977SRJ5)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
COUMARIN(UNII: A4VZ22K1WT)
GERANIOL(UNII: L837108USY)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66184-152-021 in 1 BOX
1NDC:66184-152-01113 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part332 01/01/2012

PRINCIPAL DISPLAY PANEL

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