NDC Code(s) : 43749-620-01, 43749-620-02
Packager : Unipack LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Avedana Hydrocortisone Cream with AloeHydrocortisone CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43749-620
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE(UNII: WI4X0X7BPJ)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE10.2 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETYL PALMITATE(UNII: 5ZA2S6B08X)
ISOSTEARYL NEOPENTANOATE(UNII: 411THY156Q)
METHYLPARABEN(UNII: A2I8C7HI9T)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
PEG-40 STEARATE(UNII: ECU18C66Q7)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
BENZYL ALCOHOL(UNII: LKG8494WBH)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43749-620-021 in 1 CARTON 04/07/2016
1NDC:43749-620-0128 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 04/07/2016

LABELER - Unipack LLC(009248480)

REGISTRANT - Unipack LLC(116015769)

Establishment
Name Address ID/FEI Business Operations
Unipack LLC 009248480 manufacture(43749-620)

PRINCIPAL DISPLAY PANEL

Tube Label

PRINCIPAL DISPLAY PANEL

Carton Label