ce60e1ec-a69b-4b98-a2b2-105e9cd37bc7

SPL v1
SPL
SPL Set ID ce60e1ec-a69b-4b98-a2b2-105e9cd37bc7
Route
topical
Published
Effective Date 2025-05-26
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 2025-05-23

Purpose

Antifungal

Description

Miconazole Nitrate USP, 2%


Medication Information

Warnings

For external use only

Do not use

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

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

Stop use and ask a doctor if too 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 foo twear 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 weeksor 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 tube is broken or is not visible. 
  • store at controlled room temperature 20-25°C (68-77°F)
Questions Or Comments?

(888) 885-6137


Structured Label Content

Warnings

For external use only

Do not use

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

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

Stop use and ask a doctor if too 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 foo twear 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 weeksor 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 tube is broken or is not visible. 
  • store at controlled room temperature 20-25°C (68-77°F)
Questions Or Comments? (Questions or comments?)

(888) 885-6137


Advanced Ingredient Data


Raw Label Data

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