Medpura Miconazole Nitrate 2% 

Medpura Miconazole Nitrate 2% 
SPL v2
SPL
SPL Set ID 8933f939-098a-4257-8d9c-4d5c3240e9a6
Route
TOPICAL
Published
Effective Date 2025-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Cetostearyl Alcohol Ethylparaben Glycerin Glyceryl Monostearate Mineral Oil Petrolatum Laureth-23 Water Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-19

Description

Miconazole Nitrate, USP 2%

Purpose

Anti-Fungal


Medication Information

Purpose

Anti-Fungal

Description

Miconazole Nitrate, USP 2%

Uses
  • proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
  • for effective relief of itching, scaling, cracking, burning, and discomfort
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51727-6

Inactive ingredients Cetostearyl Alcohol, EthylParaben, Glycerin, Glyceryl Monostearate, Mineral Oil, Petrolatum, Polyoxyl lauryl ether, Purified water, Stearic acid

Section 51945-4

Section 53413-1

Call toll-free 1(877)225-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

Warnings

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

When using this product, avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
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 and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks 
  • if condition lasts longer, contact a doctor + this product is not effective on the scalp or nails
Drug Facts

Active Ingredient

Miconazole Nitrate, USP 2%

Other Information
  • do not use if foil seal on tube opening is broken or missing 
  • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
  • store at room temperature 20°-25°C (68°-77°F)
  • before using any medication, read all label directions. Keep carton, it contains important information.

Structured Label Content

Uses
  • proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
  • for effective relief of itching, scaling, cracking, burning, and discomfort
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51727-6 (51727-6)

Inactive ingredients Cetostearyl Alcohol, EthylParaben, Glycerin, Glyceryl Monostearate, Mineral Oil, Petrolatum, Polyoxyl lauryl ether, Purified water, Stearic acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call toll-free 1(877)225-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

Purpose

Anti-Fungal

Warnings

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

When using this product, avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
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 and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks 
  • if condition lasts longer, contact a doctor + this product is not effective on the scalp or nails
Drug Facts

Active Ingredient (Active ingredient)

Miconazole Nitrate, USP 2%

Other Information
  • do not use if foil seal on tube opening is broken or missing 
  • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
  • store at room temperature 20°-25°C (68°-77°F)
  • before using any medication, read all label directions. Keep carton, it contains important information.

Advanced Ingredient Data


Raw Label Data

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