NDC Code(s) : 52257-1100-1, 52257-1100-2
Packager : ATOMY CO LTD

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fresh Med Solution GLYCERIN, ALCOHOL, GLYCERYL MONOSTEARATE LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52257-1100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN1.744 mL in 40 mL
ALCOHOL(UNII: 3K9958V90M)
(ALCOHOL - UNII:3K9958V90M) 		ALCOHOL1.6 mL in 40 mL
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
(GLYCERYL MONOSTEARATE - UNII:230OU9XXE4) 		GLYCERYL MONOSTEARATE0.4 mL in 40 mL
Inactive Ingredients
Ingredient Name Strength
CITRUS RETICULATA FRUIT OIL(UNII: 25P9H3QU5E)
ALTHAEA OFFICINALIS LEAF(UNII: E2QQV92338)
CHAMAEMELUM NOBILE FLOWER(UNII: O2T154T6OG)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
BITTER FENNEL(UNII: J5W36Y5WG8)
HOUTTUYNIA CORDATA FLOWERING TOP(UNII: RH041UUZ22)
LAVANDULA ANGUSTIFOLIA FLOWER(UNII: 19AH1RAF4M)
OCIMUM BASILICUM FLOWERING TOP(UNII: 7SAB275FP2)
PORTULACA OLERACEA WHOLE(UNII: D5J3623SV2)
ROSEMARY(UNII: IJ67X351P9)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(UNII: U72Q2I8C85)
MACADAMIA OIL(UNII: 515610SU8C)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALTHAEA OFFICINALIS ROOT(UNII: TRW2FUF47H)
Product Characteristics
Color white (white blue) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52257-1100-21 in 1 BOX
1NDC:52257-1100-140 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 07/18/2011

PRINCIPAL DISPLAY PANEL

ATOMY Fresh Med Solution

Net WT. 1.3 FL OZ(40ml)

image of carton label