NDC Code(s) : 70936-105-11, 70936-105-12, 70936-105-22
Packager : SMART CHOICE MEDICAL INC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AVANCE CURE INCONTINENCEALLANTOIN, DIMETHICONE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70936-105
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALLANTOIN(UNII: 344S277G0Z)
(ALLANTOIN - UNII:344S277G0Z) 		ALLANTOIN1.5 g in 100 g
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
PANTHENOL(UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
SORBIC ACID(UNII: X045WJ989B)
PHYTATE SODIUM(UNII: 88496G1ERL)
XANTHAN GUM(UNII: TTV12P4NEE)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
SHEA BUTTER(UNII: K49155WL9Y)
GLYCERIN(UNII: PDC6A3C0OX)
WHITE WAX(UNII: 7G1J5DA97F)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES(UNII: 9S60Q72309)
POLYSORBATE 60(UNII: CAL22UVI4M)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
ZINC PIDOLATE(UNII: C32PQ86DH4)
OATMEAL(UNII: 8PI54V663Y)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70936-105-11135 g in 1 TUBE Type 0: Not a Combination Product23/08/2016
2NDC:70936-105-12270 g in 1 TUBE Type 0: Not a Combination Product23/08/2016
3NDC:70936-105-22270 g in 1 JAR Type 0: Not a Combination Product23/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 08/23/2016

LABELER - SMART CHOICE MEDICAL INC.(046383276)

REGISTRANT - SMART CHOICE MEDICAL INC.(046383276)

PRINCIPAL DISPLAY PANEL

AvanceCureIncontinence

AvanceCureIncontinence