SPL v1
SPL
SPL Set ID 39d55df5-8a8e-3a9b-e063-6294a90af20b
Route
TOPICAL
Published
Effective Date 2025-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Edetate Disodium Imidazolidinyl Urea Sodium Cetearyl Sulfate Caprylic/capric Triglyceride Cetearyl Alcohol Peg-100 Stearate Propylene Glycol Glyceryl Stearate Stearic Acid Water Dimethicone Ceteareth-20 Chlorocresol Peg-40 Castor Oil Petrolatum Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-14

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

Use

Uses

  • Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm
  • Relieves itching, scaling, cracking and discomfort that can accompany these conditions
Section 51945-4

Warnings

Warnings

For external use only

Directions

Directions

  • Cleanse affected area and dry thoroughly
  • Apply thin layer to affected area twice daily (morning and night) or as directed by a physician
  • Supervise children in the use of this product
  • For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch use daily for 2 weeks
  • 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.
  • This product is not effective on the scalp or nails
Do Not Use

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

Active Ingredient

Miconazole Nitrate 2%

Inactive Ingredients

Inactive Ingredients

Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Xanthan Gum, Water

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

Use

Uses

  • Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm
  • Relieves itching, scaling, cracking and discomfort that can accompany these conditions
Section 51945-4 (51945-4)

Purpose

Antifungal

Warnings

Warnings

For external use only

Directions

Directions

  • Cleanse affected area and dry thoroughly
  • Apply thin layer to affected area twice daily (morning and night) or as directed by a physician
  • Supervise children in the use of this product
  • For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch use daily for 2 weeks
  • 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.
  • This product is not effective on the scalp or nails
Do Not Use (Do not use)

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

Active Ingredient

Miconazole Nitrate 2%

Inactive Ingredients

Inactive Ingredients

Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Xanthan Gum, Water

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

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