NDC Code(s) : 50484-328-00, 50484-329-00
Packager : Smith & Nephew, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Secura Antifungal MICONAZOLE NITRATE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50484-328
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE(UNII: VW4H1CYW1K)
(MICONAZOLE - UNII:7NNO0D7S5M) 		MICONAZOLE NITRATE20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN(UNII: 344S277G0Z)2 mg in 1 g
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)0.1 mg in 1 g
DIAZOLIDINYL UREA(UNII: H5RIZ3MPW4)2 mg in 1 g
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)40 mg in 1 g
METHYLPARABEN(UNII: A2I8C7HI9T)3 mg in 1 g
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)3 mg in 1 g
PETROLATUM(UNII: 4T6H12BN9U)150 mg in 1 g
PROPYLPARABEN(UNII: Z8IX2SC1OH)1.5 mg in 1 g
SODIUM CETOSTEARYL SULFATE(UNII: 7ZBS06BH4B)7 mg in 1 g
SODIUM CITRATE(UNII: 1Q73Q2JULR)23.5 mg in 1 g
WATER(UNII: 059QF0KO0R)594.4 mg in 1 g
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)109 mg in 1 g
CETETH-20(UNII: I835H2IHHX)10 mg in 1 g
ETHYLHEXYL PALMITATE(UNII: 2865993309)8 mg in 1 g
POLYOXYL 40 CASTOR OIL(UNII: 4ERD2076EF)14 mg in 1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50484-328-0057 g in 1.0 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 08/01/2003 06/30/2018
Secura Antifungal MICONAZOLE NITRATE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50484-329
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE(UNII: VW4H1CYW1K)
(MICONAZOLE - UNII:7NNO0D7S5M) 		MICONAZOLE NITRATE20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZETHONIUM CHLORIDE(UNII: PH41D05744)1.3 mg in 1 g
BUTYLPARABEN(UNII: 3QPI1U3FV8)0.5 mg in 1 g
DIAZOLIDINYL UREA(UNII: H5RIZ3MPW4)2 mg in 1 g
KARAYA GUM(UNII: 73W9IQY50Q)70 mg in 1 g
METHYLPARABEN(UNII: A2I8C7HI9T)3 mg in 1 g
MINERAL OIL(UNII: T5L8T28FGP)40 mg in 1 g
PETROLATUM(UNII: 4T6H12BN9U)400 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)300 mg in 1 g
WATER(UNII: 059QF0KO0R)21.2 mg in 1 g
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)2 mg in 1 g
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)60 mg in 1 g
CARBOXYMETHYLCELLULOSE(UNII: 05JZI7B19X)30 mg in 1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50484-329-0092 g in 1.0 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333C 08/01/2003 06/30/2018

PRINCIPAL DISPLAY PANEL


PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA ANTIFUNGAL GREASELESS - TUBE(57g)

Item #59432800

NDC 50484-328-00

Antifungal Greaseless

  • 2% Miconazole Nitrate
  • Cures most jock itch (tinea cruris), ringworm (tinea corporis), and athlete's foot (tinea pedis)
  • Relieves burning, itching, scaling, cracking, chafing and redness associated with these conditions
  • Pediatrician tested

Smith & Nephew

Secura◊

Antifungal Greaseless

Made in India for:
Smith & Nephew, Inc., St. Petersburg, FL 33716 

Trademark of Smith & Nephew

Reg. U.S. Pat & Tm. Off.

Package Display - Antifungal Greaseless



PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA ANTIFUNGAL EXTRA THICK  - TUBE(92g)

Item #59432900

NDC 50484-329-00

Antifungal Greaseless

  • 2% Miconazole Nitrate
  • Cures most jock itch (tinea cruris), ringworm (tinea corporis), and athlete's foot (tinea pedis)
  • Relieves burning, itching, scaling, cracking, chafing and redness associated with these conditions
  • Can be used on denuded skin
  • Pediatrician tested

Smith & Nephew

Secura◊

Antifungal Extra Thick

Made in India for:
Smith & Nephew, Inc., St. Petersburg, FL 33716 

www.smith-nephew.com

Trademark of Smith & Nephew

Reg. U.S. Pat & Tm. Off.


Package Display - Antifungal Greaseless