DRUG FACTS

ACTIVE INGREDIENTS

Miconazole nitrate 2%

PURPOSE

Antifungal

USES

Antifungal Extra Thick

Cures most jock itch (tinea cruris), ringworm (tinea corporis) and athlete's foot (tinea pedis)

Antifungal Greaseless

Cures most athlete's foot, jock itch and ringworm

WARNINGS

For external use only
Do not use on children under 2 years old unless directed by a doctor

Avoid contact with the eyes
Stop use and ask a doctor if irritation occurs or if there is no improvement
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

KEEP OUT OF REACH OF CHILDREN

Keep reach out of children. If swallowed, get medical help or contact a Poison Control Center immediately

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?

1 800 876-1261

INACTIVIE INGREDIENTS

Antifungal Greaseless

allantoin, cetearyl alcohol, ceteth-20, citric acid, diazolidinyl urea, dioctyl adipate, glyceryl stearate, methylparaben, octyl palmitate, octyl stearate, PEG-40 castor oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium citrate, tocopheryl acetate, water

Antifungal Extra Thick

benzethonium chloride, butylparaben, cellulose gum, cetearyl alcohol, diazolidinyl urea, karaya gum, methylparaben, methyl glucose dioleate, mineral oil, petrolatum, tocopheryl acetate, water, zinc oxide

OTHER INFORMATION

Store at controlled room temperature 59°F-86°F (15°C-30°C)

SECURA ANTIFUNGAL EXTRA THICK/SECURA ANTIFUNGAL GREASELESS

Store at controlled room temperature 59 oF-86 oF (15 oC-30 oC)

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, England

Trademark of Smith & Nephew

Certain Marks Reg'd U.S. Pat & Tm. Off.

69740-328

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 England

Trademark of Smith & Nephew

Certain marks Reg'd U.S. Pat & Tm. Off.

secura-antifungal-fig-92g

SECURA ANTIFUNGAL GREASELESS
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69740-328
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIHEPTYL ADIPATE (UNII: 2M01ZJ4HJB)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
OCTYL PALMITATE (UNII: UYY8LE6Q5Y)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
OCTYL STEARATE (UNII: 772Y4UFC8B)
ALLANTOIN (UNII: 344S277G0Z)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69740-328-00	57 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M005	08/01/2003

SECURA ANTIFUNGAL EXTRA THICK
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69740-329
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
KARAYA GUM (UNII: 73W9IQY50Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
ZINC OXIDE (UNII: SOI2LOH54Z)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69740-329-00	92 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2003

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M005	08/01/2003

Labeler - Smith & Nephew Medical Ltd (216344051)

Name	Address	ID/FEI	Business Operations
Establishment
ENCUBE ETHICALS PVT LTD		725076298	manufacture(69740-328, 69740-329)

Secura Antifungal

DRUG FACTS

ACTIVE INGREDIENTS

PURPOSE

USES

WARNINGS

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS

QUESTION OR COMMENTS?

INACTIVIE INGREDIENTS

OTHER INFORMATION

SECURA ANTIFUNGAL EXTRA THICK﻿/SECURA ANTIFUNGAL GREASELESS

SECURA ANTIFUNGAL EXTRA THICK/SECURA ANTIFUNGAL GREASELESS