NDC Code(s) : 0462-0358-15, 0462-0358-30, 0462-0358-60, 0462-0359-30, 0462-0359-60
Packager : PharmaDerm, A division of Nycomed US Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Oxistatoxiconazole nitrate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0462-0358
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
oxiconazole nitrate(UNII: RQ8UL4C17S)
(oxiconazole - UNII:C668Q9I33J) 		oxiconazole nitrate10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
petrolatum(UNII: 4T6H12BN9U)
stearyl alcohol(UNII: 2KR89I4H1Y)
propylene glycol(UNII: 6DC9Q167V3)
polysorbate 60(UNII: CAL22UVI4M)
cetyl alcohol(UNII: 936JST6JCN)
benzoic acid(UNII: 8SKN0B0MIM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0462-0358-151 in 1 CARTON
115 g in 1 TUBE
2NDC:0462-0358-301 in 1 CARTON
230 g in 1 TUBE
3NDC:0462-0358-601 in 1 CARTON
360 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019828 01/25/2006
Oxistatoxiconazole nitrate LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0462-0359
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
oxiconazole nitrate(UNII: RQ8UL4C17S)
(oxiconazole - UNII:C668Q9I33J) 		oxiconazole nitrate10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
petrolatum(UNII: 4T6H12BN9U)
stearyl alcohol(UNII: 2KR89I4H1Y)
propylene glycol(UNII: 6DC9Q167V3)
polysorbate 60(UNII: CAL22UVI4M)
cetyl alcohol(UNII: 936JST6JCN)
benzoic acid(UNII: 8SKN0B0MIM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0462-0359-301 in 1 CARTON
130 g in 1 BOTTLE, WITH APPLICATOR
2NDC:0462-0359-601 in 1 CARTON
260 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020209 01/25/2006

PRINCIPAL DISPLAY PANEL

PharmaDerm®

NDC 0462-0358-60

Oxistat® Cream, 1%*

(oxiconazole nitrate cream)

*Potency expressed as oxiconazole.

For Topical Dermatologic Use ONLY – Not for Ophthalmic or Intravaginal Use.

Rx only

60 g

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60 G CARTON

PRINCIPAL DISPLAY PANEL

PharmaDerm®

NDC 0462-0359-30

Oxistat®

(oxiconazole nitrate lotion)

Lotion, 1%*

*Potency expressed as oxiconazole.

For Topical Dermatologic Use ONLY – Not for Ophthalmic or Intravaginal Use

Rx only

30 mL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 ML CARTON