NDC Code(s) : 53389-231-14
Packager : MEGASOL COSMETIC GMBH

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EROS LONG STAY SILICONE GLIDE DIMETHICONE GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53389-231
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE30 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONOL (100000 CST)(UNII: OSA9UP217S)
PLUKENETIA VOLUBILIS SEED OIL(UNII: 8ED72Z8J1Z)
SCHINUS TEREBINTHIFOLIUS WHOLE(UNII: X6763LQ3TQ)
LIMONENE, ()-(UNII: 9MC3I34447)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53389-231-14100 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 10/01/2012

PRINCIPAL DISPLAY PANEL

Long-Stay-Silicone-Glide_ER23100_DFBox

Long-Stay-Silicone-Glide_ER23100_DFBox