3d375325-ddad-f1e1-e063-6394a90a679f

SPL v1
SPL
SPL Set ID 3d375325-ddad-f1e1-e063-6394a90a679f
Route
topical
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
miconazole (2 g)
Inactive Ingredients
starch, corn sodium benzoate glycyrrhizinate dipotassium silicon dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-12-01

Purpose

Antifungal

Description

Mconazole Nitrate 2%


Medication Information

Warnings

Warnings

For external use only

Uses

Uses

  • Proven clinically effective in the treatment of most athlete’s foot, jock itch and ringworm
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomforts associated with all three treatments. Also relieves chaffing associated with jock itch.
Purpose

Antifungal

Directions

Directions

  • clean affected area and dry thoroughly
  • apply thin layer of powder to 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 pay special attention to space between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch use daily for 2 weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
Inactive Ingredients

Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Dipotassium Glycyrrhizinate, Sodium Benzoate

Description

Mconazole Nitrate 2%

Section 51945-4

Do Not Use

Do not use on children under 2 years of age unless directed by a doctor

Active Ingredient

Mconazole Nitrate 2%

When Using This Product

When using this product avoid contact with eyes

Keep Out of Reach of Children

Keep out of reach of Children. In case of accidental ingestion, contact a physician or Poison Control Center right away.

Stop Using and Ask A Doctor If

Stop using and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or 2 weeks (for jock itch)

Structured Label Content

Warnings

Warnings

For external use only

Uses

Uses

  • Proven clinically effective in the treatment of most athlete’s foot, jock itch and ringworm
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomforts associated with all three treatments. Also relieves chaffing associated with jock itch.
Purpose

Antifungal

Directions

Directions

  • clean affected area and dry thoroughly
  • apply thin layer of powder to 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 pay special attention to space between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch use daily for 2 weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
Inactive Ingredients

Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Dipotassium Glycyrrhizinate, Sodium Benzoate

Section 51945-4 (51945-4)

Do Not Use (Do not use)

Do not use on children under 2 years of age unless directed by a doctor

Active Ingredient

Mconazole Nitrate 2%

When Using This Product (When using this product)

When using this product avoid contact with eyes

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of Children. In case of accidental ingestion, contact a physician or Poison Control Center right away.

Stop Using and Ask A Doctor If (Stop using and ask a doctor if)

Stop using and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or 2 weeks (for jock itch)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)