e13eb653-3916-444a-ae86-1738c0308b79

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

Purpose

Antifungal

Description

Miconazole Nitrate 2%


Medication Information

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 
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

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
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.

Description

Miconazole Nitrate 2%

Principal Display Panel

Questions?

call toll free 1-800-630-8895

Active Ingredient

Miconazole Nitrate 2%

Keep Out of Reach of Children.

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


Structured Label Content

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 
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

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
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

Questions?

call toll free 1-800-630-8895

Active Ingredient

Miconazole Nitrate 2%

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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