NDC Code(s) : 59078-134-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Premium RX Horse Yu Hand CreamGlycerin CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-134
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN3147.5 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
PHENOXYETHANOL(UNII: HIE492ZZ3T)
MATRICARIA CHAMOMILLA WHOLE(UNII: 2Z4LRR776S)
GENTIANA LUTEA ROOT(UNII: S72O3284MS)
PORTULACA OLERACEA WHOLE(UNII: D5J3623SV2)
ALLANTOIN(UNII: 344S277G0Z)
ARTEMISIA ABSINTHIUM WHOLE(UNII: 51PW3BIW1K)
WATER(UNII: 059QF0KO0R)
MINERAL OIL(UNII: T5L8T28FGP)
PEG-100 STEARATE(UNII: YD01N1999R)
DIMETHICONE(UNII: 92RU3N3Y1O)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
CERAMIDE 3(UNII: 4370DF050B)
ACER SACCHARUM WHOLE(UNII: KEG5092LU9)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
LAURETH-7(UNII: Z95S6G8201)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-134-011 in 1 CARTON 19/01/2016
150 mL in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 01/14/2016

PRINCIPAL DISPLAY PANEL

product