SPL v1
SPL
SPL Set ID 85e98ef8-75c3-4be1-b59f-40b5312e2137
Route
TOPICAL
Published
Effective Date 2025-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Tea Tree Oil Benzoic Acid Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Olive Oil Potassium Hydroxide Propylene Glycol Water Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-27

Description

Miconazole Nitrate USP, 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate USP, 2%

Uses
  • cures most athlete’s foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany theses conditions
Section 50565-1

Warnings

For external use only

Do not use

  • on scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

When using this productdo not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor iftoo much irritation occurs or gets worse

  • Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and over:

  • wash affected area with soap and water and dry completely before applying
  • for athlet's footwear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
  • between the tose only:apply twice a day (morning and night) for 1 weekor as directed by doctor
  • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by doctor
  • for jock itch and ringworm: apply once a day (morning ornight) for 1 weekor as directed by a doctor
  • wash hands after each use
  • Children under 12 years: ask a doctor
Product Label

Active Ingredient

Miconazole Nitrate USP, 2%

Other Information 
  • do not use if seal on the box is broken or is not visible.
  • store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients

Organic tea tree oil, benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, olive oil, potassium hydroxide, propylene glycol, water, stearyl alcohol


Structured Label Content

Uses
  • cures most athlete’s foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany theses conditions
Section 50565-1 (50565-1)

Purpose

Antifungal

Warnings

For external use only

Do not use

  • on scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

When using this productdo not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor iftoo much irritation occurs or gets worse

  • Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and over:

  • wash affected area with soap and water and dry completely before applying
  • for athlet's footwear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
  • between the tose only:apply twice a day (morning and night) for 1 weekor as directed by doctor
  • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by doctor
  • for jock itch and ringworm: apply once a day (morning ornight) for 1 weekor as directed by a doctor
  • wash hands after each use
  • Children under 12 years: ask a doctor
Product Label (Product label)

Active Ingredient

Miconazole Nitrate USP, 2%

Other Information 
  • do not use if seal on the box is broken or is not visible.
  • store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

Organic tea tree oil, benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, olive oil, potassium hydroxide, propylene glycol, water, stearyl alcohol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)