85e98ef8-75c3-4be1-b59f-40b5312e2137

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

Purpose

Antifungal

Description

Miconazole Nitrate USP, 2%


Medication Information

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.

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
Purpose

Antifungal

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
Inactive Ingredients

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

Description

Miconazole Nitrate USP, 2%

Section 50565-1

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)

Structured Label Content

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.

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
Purpose

Antifungal

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
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

Section 50565-1 (50565-1)

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)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)