NDC Code(s) : 24765-104-01, 24765-104-02
Packager : Pharmacal-International. Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr. SerseGLYCERIN CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24765-104
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN0.175 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
SODIUM LACTATE(UNII: TU7HW0W0QT)
PEG-60 HYDROGENATED CASTOR OIL(UNII: 02NG325BQG)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
CHLORPHENESIN(UNII: I670DAL4SZ)
ARGININE(UNII: 94ZLA3W45F)
ALLANTOIN(UNII: 344S277G0Z)
XANTHAN GUM(UNII: TTV12P4NEE)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
JOJOBA OIL(UNII: 724GKU717M)
SQUALANE(UNII: GW89575KF9)
ROSA CENTIFOLIA FLOWER OIL(UNII: H32V31VMWY)
EUCALYPTUS GLOBULUS LEAF(UNII: S546YLW6E6)
ASPALATHUS LINEARIS LEAF(UNII: H7UGK1GJCU)
MATRICARIA RECUTITA FLOWERING TOP(UNII: 3VNC7T6Z02)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
VISCUM ALBUM FRUITING TOP(UNII: BK9092J5MP)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ROSEMARY(UNII: IJ67X351P9)
LAVANDULA ANGUSTIFOLIA FLOWER(UNII: 19AH1RAF4M)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ACETYL HEXAPEPTIDE-8(UNII: L4EL31FWIL)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24765-104-028 in 1 BOX 10/07/2016
1NDC:24765-104-015 mL in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/07/2016

PRINCIPAL DISPLAY PANEL

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