Secura Antifungal

Secura Antifungal
SPL v12
SPL
SPL Set ID 9be600e4-76ec-4071-a8ec-a0b23155271d
Route
TOPICAL
Published
Effective Date 2025-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Diheptyl Adipate Peg-40 Castor Oil Propylparaben Octyl Palmitate Anhydrous Citric Acid Octyl Stearate Allantoin Diazolidinyl Urea Glyceryl Monostearate Methylparaben Alpha-tocopherol Acetate Petrolatum Sodium Cetostearyl Sulfate Sodium Citrate Water Cetostearyl Alcohol Ceteth-20 Methyl Glucose Dioleate Benzethonium Chloride Butylparaben Xanthan Gum Mineral Oil Zinc Oxide Carboxymethylcellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2003-08-01

Description

Miconazole nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole nitrate 2%

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



Section 51945-4

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

Item #59432900

NDC 69740-329-00

Antifungal Extra Thick

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.

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.

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

  • Avoid contact with the eyes
  • For jock itch: If irritation occurs or it there is no improvement within 2 weeks, discontinue use and consult a doctor
  • For the treatment of athlete's foot and ringworm: If irritaion occurs or it there is no improvement within 4 weeks, discontinue use and consult a doctor
  • Keep out of reach 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) or as directed by a doctor
  • 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.

Active Ingredients

Miconazole nitrate 2%

Question Or Comments?

1 800 876-1261

inactive 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, diazolidinyl urea, methylparaben, methyl glucose dioleate, mineral oil, petrolatum, tocopheryl acetate, water, xanthan gum, zinc oxide

Keep Out of Reach of Children
  • Keep reach out of children. If swallowed, get medical help or contact a Poison Control Center immediately
Updated in Line With Latest Otc Monograph

Addition of 'Unless directed by doctor' to 'Do not use on children under 2 years old'.

Separation and expansion of 'For jock itch' and 'For athlete's foot and ringworm' warnings


Structured Label Content

Uses (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



Section 51945-4 (51945-4)

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

Item #59432900

NDC 69740-329-00

Antifungal Extra Thick

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.

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.

Purpose (PURPOSE)

Antifungal

Warnings (WARNINGS)
  • For external use only
  • Do not use on children under 2 years old unless directed by a doctor

  • Avoid contact with the eyes
  • For jock itch: If irritation occurs or it there is no improvement within 2 weeks, discontinue use and consult a doctor
  • For the treatment of athlete's foot and ringworm: If irritaion occurs or it there is no improvement within 4 weeks, discontinue use and consult a doctor
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately
Directions (DIRECTIONS)
  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • 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.

Active Ingredients (ACTIVE INGREDIENTS)

Miconazole nitrate 2%

Question Or Comments? (QUESTION OR COMMENTS?)

1 800 876-1261

inactive Ingredients (INACTIVE 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, diazolidinyl urea, methylparaben, methyl glucose dioleate, mineral oil, petrolatum, tocopheryl acetate, water, xanthan gum, zinc oxide

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)
  • Keep reach out of children. If swallowed, get medical help or contact a Poison Control Center immediately
Updated in Line With Latest Otc Monograph (Updated in line with latest OTC Monograph)

Addition of 'Unless directed by doctor' to 'Do not use on children under 2 years old'.

Separation and expansion of 'For jock itch' and 'For athlete's foot and ringworm' warnings


Advanced Ingredient Data


Raw Label Data

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