SPL v1
SPL
SPL Set ID e13eb653-3916-444a-ae86-1738c0308b79
Route
TOPICAL
Published
Effective Date 2025-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Allantoin Chloroxylenol Starch, Corn Imidurea Microcrystalline Cellulose Tricalcium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

Uses
  • for the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) 
  • for the treatment of most superficial skin infections caused by yeast (candida albicans)
  • relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch 
Warnings

For external use only.

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

When using this product avoid contact with the eyes.

Stop and ask a doctor if

  • for athlete’s foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks
  • for jock itch - if irritation occurs, or if there is no improvement within 2 weeks 
Directions
  • clean the affected area and dry thoroughly
  • apply a thin layer of powder over 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 spaces 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 conditions persist longer, consult a doctor
  • this product is not effective on the scalp or nails
Questions?

call toll free 1-800-630-8895

Active Ingredient

Miconazole Nitrate 2%

Other Information
  • Store between 20º to 25ºC (68º to 77ºF)
  • Protect from freezing. Avoid excessive heat.
  • Do not use if package is damaged.
Inactive Ingredients

allantoin, chloroxylenol, corn starch, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate.

Principal Display Panel

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • for the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) 
  • for the treatment of most superficial skin infections caused by yeast (candida albicans)
  • relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch 
Purpose

Antifungal

Warnings

For external use only.

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

When using this product avoid contact with the eyes.

Stop and ask a doctor if

  • for athlete’s foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks
  • for jock itch - if irritation occurs, or if there is no improvement within 2 weeks 
Directions
  • clean the affected area and dry thoroughly
  • apply a thin layer of powder over 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 spaces 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 conditions persist longer, consult a doctor
  • this product is not effective on the scalp or nails
Questions?

call toll free 1-800-630-8895

Active Ingredient

Miconazole Nitrate 2%

Other Information (Other information)
  • Store between 20º to 25ºC (68º to 77ºF)
  • Protect from freezing. Avoid excessive heat.
  • Do not use if package is damaged.
Inactive Ingredients (Inactive ingredients)

allantoin, chloroxylenol, corn starch, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate.

Principal Display Panel

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

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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