NDC Code(s) : 39765-002-01
Packager : Neutraderm Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

HQRA-OTC Hydroquinone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:39765-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE(UNII: XV74C1N1AE)
(HYDROQUINONE - UNII:XV74C1N1AE) 		HYDROQUINONE2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
DIMETHICONE(UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
GLYCERIN(UNII: PDC6A3C0OX)
RETINOL(UNII: G2SH0XKK91)
CETYL ALCOHOL(UNII: 936JST6JCN)
POLYSORBATE 20(UNII: 7T1F30V5YH)
GLYCOL DISTEARATE(UNII: 13W7MDN21W)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
ETHYLHEXYL METHOXYCRYLENE(UNII: S3KFG6Q5X8)
KOJIC ACID(UNII: 6K23F1TT52)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DULSE(UNII: 7832HOY4ZQ)
SUNFLOWER OIL(UNII: 3W1JG795YI)
ALLANTOIN(UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
HYDROCORTISONE(UNII: WI4X0X7BPJ)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
CARBOMER COPOLYMER TYPE A(UNII: 71DD5V995L)
SODIUM ACRYLATE(UNII: 7C98FKB43H)
SODIUM ACRYLOYLDIMETHYLTAURATE(UNII: 2T9Q6EKI0G)
ISOHEXADECANE(UNII: 918X1OUF1E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
TROLAMINE(UNII: 9O3K93S3TK)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
EDETATE SODIUM(UNII: MP1J8420LU)
SODIUM METABISULFITE(UNII: 4VON5FNS3C)
Product Characteristics
Color yellow (Light Yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:39765-002-0150 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part358A 12/01/2009

PRINCIPAL DISPLAY PANEL

Product Label