NDC Code(s) : 17500-2101-4
Packager : Kingkey Daily Chemical Co LTD

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dermasil Dimethicone LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17500-2101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE1 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PETROLATUM(UNII: 4T6H12BN9U)
MINERAL OIL(UNII: T5L8T28FGP)
GLYCERIN(UNII: PDC6A3C0OX)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLYCOL STEARATE(UNII: 0324G66D0E)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CETYL ALCOHOL(UNII: 936JST6JCN)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
METHYLPARABEN(UNII: A2I8C7HI9T)
HELIANTHUS ANNUUS(UNII: BKJ0J3D1BP)
CETYLPYRIDINIUM ACETATE(UNII: 6W29RZ7YU2)
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
EDETATE DISODIUM(UNII: 7FLD91C86K)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
BORAGE(UNII: PB618V0K2W)
CHOLESTEROL(UNII: 97C5T2UQ7J)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ALMOND(UNII: 3Z252A2K9G)
VANILLA(UNII: Q74T35078H)
GERANIUM EXTRACT(UNII: 6H429I0Y3L)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:17500-2101-4296 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 10/15/2009

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 10 FL.0Z (5/8 PINT. 296 ml)

Tube Label Dermasil 10oz
25% MORE
Dermasil ®
LABS
Pharmaceutical Research
Controls Even Severe Dry Skin
Skin Lipid & EFA Treatment
Hypo-Allergenic
Dermasil ®
Dry Skin Treatment
ORIGINAL LOTION
10 FL.0Z (5/8 PINT. 296 ml)

Principal Display Panel - 10 FL.0Z (5/8 PINT. 296 ml)