NDC Code(s) : 55315-341-56
Packager : Fred's Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Hydrocortisone Hydrocortisone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55315-341
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE(UNII: WI4X0X7BPJ)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE(UNII: V5VD430YW9)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETYL ALCOHOL(UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
CORN OIL(UNII: 8470G57WFM)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
METHYLPARABEN(UNII: A2I8C7HI9T)
MINERAL OIL(UNII: T5L8T28FGP)
POLYOXYL 40 STEARATE(UNII: 13A4J4NH9I)
POLYSORBATE 60(UNII: CAL22UVI4M)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SORBIC ACID(UNII: X045WJ989B)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
VITAMIN A(UNII: 81G40H8B0T)
VITAMIN D(UNII: 9VU1KI44GP)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
PETROLATUM(UNII: 4T6H12BN9U)
WHITE WAX(UNII: 7G1J5DA97F)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55315-341-561 in 1 CARTON 01/05/2009
128 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 NOT FINAL part348 05/01/2009 04/30/2018

PRINCIPAL DISPLAY PANEL

fred's Pharmacy

NDC 55315-341-56

Maximum Strength
Hydrocortisone +12
(HYDROCORTISONE CREAM, USP 1% WITH 12 MOISTURIZERS)

·         For Skin Irritations, Inflammation & Rashes
·         For Eczema & Psoriasis
·         Enriched with Aloe Plus Vitamins A & E

ANTI-ITCH CREAM
Compare To The Active Ingredient in: *Cortizone•10® Plus Maximum Strength
NET WT 1 OZ (28g)

Hydrocortisone +12 Cream, with Aloe