SECURA ANTIFUNGAL GREASELESS- miconazole nitrate cream SECURA ANTIFUNGAL EXTRA THICK- miconazole nitrate cream

Secura Antifungal by

Drug Labeling and Warnings

Secura Antifungal by is a Otc medication manufactured, distributed, or labeled by Smith & Nephew Medical Ltd, ENCUBE ETHICALS PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Keep reach out of children. In case of ingestion, 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

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

SECURA 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

SECURA ANTIFUNGAL EXTRA THICK/SECURA ANTIFUNGAL GREASELESS

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

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, England

Trademark 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 England

Trademark of Smith & Nephew

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

INGREDIENTS AND APPEARANCE

SECURA ANTIFUNGAL  GREASELESS
miconazole nitrate cream

Product 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 cream

Product 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)