NDC Code(s) : 59535-2701-1
Packager : AMI Cosmetic Co.,Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ULTRA HYDRA GLYCERIN CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59535-2701
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN0.1 g in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PENTAERYTHRITYL TETRAISOSTEARATE(UNII: 9D7IK5483F)
NEOPENTYL GLYCOL DICAPRATE(UNII: 77T908SE82)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59535-2701-170 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/01/2013

PRINCIPAL DISPLAY PANEL

package label