NDC | 69740-328-00, 69740-329-00 |
Set ID | 9be600e4-76ec-4071-a8ec-a0b23155271d |
Category | HUMAN OTC DRUG LABEL |
Packager | Smith & Nephew Medical Ltd |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- DRUG FACTS
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- clean the affected area and dry thoroughly
- apply a thin layer of the product over affected area twice daily (morning and night)
- supervise children in the use of this product
For athlete's foot:
- pay special attention to the spaces between the toes
- wear well fitting, ventilated shoes
- change shoes and socks at least once daily
For athlete's foot and ringworm use daily for 4 weeks.
For jock itch use daily for 2 weeks.
If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.
- QUESTION OR COMMENTS?
-
INACTIVE INGREDIENTS
SECURA ANTIFUNGAL GREASELESS
allantoin, cetearyl alcohol, polyethylene glycol 1000 cetyl ether, citric acid, diazolidinyl urea, dioctyl adipate, glyceryl stearate, methylparaben, octyl palmitate, octyl stearate, PEG-40 castor oil, petrolatum, o-phenylphenol, propylparaben, sodium cetearyl sulfate, sodium citrate, tocopheryl acetate, water
- OTHER INFORMATION
-
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL- SECURA ANTIFUNGAL GREASELESS - TUBE(57g)
Item #59432800
NDC 69740-328-00
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
- Pediatric tested
- CHG compatible
Smith & Nephew
Secura◊
Antifungal Greaseless
Made in India for:
Smith & Nephew Medical Ltd, 101 Hessle Road, Hull HU3 2BN, EnglandTrademark of Smith & Nephew
Certain Marks Reg'd U.S. Pat & Tm. Off.
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - SECURA ANTIFUNGAL EXTRA THICK - TUBE(92g)
Item #59432900
NDC 69740-329-00
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
- Pediatric tested
- CHG Compatible
- Can be used on denuded skin
Smith & Nephew
Secura◊
Antifungal Extra Thick
Made in India for:
Smith & Nephew Medical Ltd, 101 Hessle Road, Hull, HU3 2BN EnglandTrademark of Smith & Nephew
Certain marks Reg'd U.S. Pat & Tm. Off.
-
INGREDIENTS AND APPEARANCE
SECURA ANTIFUNGAL GREASELESS
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69740-328 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) 2 mg in 1 g CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 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 1 NDC:69740-328-00 57 g in 1.0 TUBE; Type 0: Not a Combination Product 08/01/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/01/2003 SECURA ANTIFUNGAL EXTRA THICK
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69740-329 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 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 1 NDC:69740-329-00 92 g in 1.0 TUBE; Type 0: Not a Combination Product 08/01/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/01/2003 Labeler - Smith & Nephew Medical Ltd (216344051) Establishment Name Address ID/FEI Business Operations ENCUBE ETHICALS PVT LTD 725076298 MANUFACTURE(69740-328, 69740-329)