NDC Code(s) : 70936-109-11
Packager : SMART CHOICE MEDICAL INC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Avance Cure Antibacterial Perineal WashBenzethonium chloride SOLUTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70936-109
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZETHONIUM CHLORIDE(UNII: PH41D05744)
(BENZETHONIUM - UNII:1VU15B70BP) 		BENZETHONIUM CHLORIDE0.12 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
PALMITAMIDOPROPYLTRIMONIUM CHLORIDE(UNII: N2U96D202F)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70936-109-11240 mL in 1 BOTTLE Type 0: Not a Combination Product07/02/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M003 08/22/2016

LABELER - SMART CHOICE MEDICAL INC.(046383276)

REGISTRANT - SMART CHOICE MEDICAL INC.(046383276)

PRINCIPAL DISPLAY PANEL

Temp LBL_Antibacterial Perineal Wash