eb953281-cf86-44cf-a3d1-37b8d344a6bc

SPL v1
SPL
SPL Set ID eb953281-cf86-44cf-a3d1-37b8d344a6bc
Route
topical
Published
Effective Date 2026-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
miconazole (2 g)
Inactive Ingredients
water propylene glycol stearyl alcohol dimethicone, unspecified isopropyl alcohol sodium lauryl sulfate benzyl alcohol hydroxyethyl cellulose, unspecified ethylparaben propylparaben sodium chloride

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-14

Purpose

Anti-fungal

Description

Miconazole Nitrate 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 the 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses
  • effectively treats most of  cases of ringworm (tinea corporis) and related fungal infections.
  • helps relieve itching, redness, flaking, and irritation commonly associated with ringworm and similar skin conditions.
Purpose

Anti-fungal

Directions

Adults and children 12 years and over

  • Wash the affected skin with soap and water and dry completely before applying.
  • for ringworm: apply a thin layer to the affected skin once daily (morning  or night) for 1 week, or as directed by a doctor
  • severe or persistent cases: use twice daily (morning  and evening) for up to 2 weeks, or as directed by a doctor
  • allow the product to fully dry on the skin before dressing
  • wash hands after each use children under 12 years: ask a doctor.
Other Information
  • do not use if seal on box is brken 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, Oxygenated olive oil, Potassium hydroxide, Propylene glycol, Purified water, Stearyl alcohol, Mel (Manuka Honey) Extract.

Description

Miconazole Nitrate 2%

Section 50565-1

Drug Facts

Product Label

Active Ingredient

Miconazole Nitrate 2%


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 the 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses
  • effectively treats most of  cases of ringworm (tinea corporis) and related fungal infections.
  • helps relieve itching, redness, flaking, and irritation commonly associated with ringworm and similar skin conditions.
Purpose

Anti-fungal

Directions

Adults and children 12 years and over

  • Wash the affected skin with soap and water and dry completely before applying.
  • for ringworm: apply a thin layer to the affected skin once daily (morning  or night) for 1 week, or as directed by a doctor
  • severe or persistent cases: use twice daily (morning  and evening) for up to 2 weeks, or as directed by a doctor
  • allow the product to fully dry on the skin before dressing
  • wash hands after each use children under 12 years: ask a doctor.
Other Information
  • do not use if seal on box is brken 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, Oxygenated olive oil, Potassium hydroxide, Propylene glycol, Purified water, Stearyl alcohol, Mel (Manuka Honey) Extract.

Section 50565-1 (50565-1)

Drug Facts

Product Label (Product label)

Active Ingredient

Miconazole Nitrate 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)