NDC Code(s) : 52257-1110-1, 52257-1110-2
Packager : ATOMY CO LTD

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Calming Skin PANTHENOL, GLYCERIN, TOCOPHEROL LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52257-1110
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANTHENOL(UNII: WV9CM0O67Z)
(PANTHENOL - UNII:WV9CM0O67Z) 		PANTHENOL0.65 mL in 130 mL
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN0.65 mL in 130 mL
TOCOPHEROL(UNII: R0ZB2556P8)
(TOCOPHEROL - UNII:R0ZB2556P8) 		TOCOPHEROL0.65 mL in 130 mL
Inactive Ingredients
Ingredient Name Strength
ALTHAEA OFFICINALIS LEAF(UNII: E2QQV92338)
ALTHAEA OFFICINALIS ROOT(UNII: TRW2FUF47H)
CHAMAEMELUM NOBILE FLOWER(UNII: O2T154T6OG)
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)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
PHELLINUS LINTEUS WHOLE(UNII: YVO92B1UCA)
CERAMIDE 3(UNII: 4370DF050B)
CITRUS RETICULATA FRUIT OIL(UNII: 25P9H3QU5E)
HYDROGENATED SOYBEAN LECITHIN(UNII: H1109Z9J4N)
MACADAMIA OIL(UNII: 515610SU8C)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
UBIDECARENONE(UNII: EJ27X76M46)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52257-1110-21 in 1 BOX
1NDC:52257-1110-1130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/18/2011

PRINCIPAL DISPLAY PANEL

ATOMY Calming skin

Net WT. 4.39 FL OZ(130ml)

image of carton label