Antifungal

Antifungal
SPL v4
SPL
SPL Set ID 853f5d10-99c3-4fdc-87b9-0ee6826e84ad
Route
TOPICAL
Published
Effective Date 2013-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Ceteth-20 Cetostearyl Alcohol Chlorocresol Light Mineral Oil Propylene Glycol Water Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-07-18
Description

Miconazole Nitrate 2%

Medication Information

Description

Miconazole Nitrate 2%

Warnings

Do not use:

  • Do not use on children under 2 years of age unless directed by a doctor.
  • Avoid contact with eyes.
  • For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions




  • Supervise children in the use of this product.
  • If conditions persist longer, consult a doctor.
  • This product is not effective on scalp or nails.

Active Ingredient

Miconazole Nitrate 2%

Uses Antifungal
  • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
  • For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
Other Information.

Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, white soft paraffin.

Principal Display Panel

Principal Display Panel

Miconazole Nitrate Cream USP 2%



Gal Miconazole.jpg

Keep Out of Reach of Children
  • KEEP OUT OF REACH OF CHILDREN
  • If swallowed get medical help or contact a Poison Control Center.

Structured Label Content

Warnings

Do not use:

  • Do not use on children under 2 years of age unless directed by a doctor.
  • Avoid contact with eyes.
  • For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions




  • Supervise children in the use of this product.
  • If conditions persist longer, consult a doctor.
  • This product is not effective on scalp or nails.

Active Ingredient

Miconazole Nitrate 2%

Uses Antifungal (Uses - Antifungal)
  • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
  • For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
Other Information. (Other information.)

Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, white soft paraffin.

Principal Display Panel

Principal Display Panel

Miconazole Nitrate Cream USP 2%



Gal Miconazole.jpg

Keep Out of Reach of Children
  • KEEP OUT OF REACH OF CHILDREN
  • If swallowed get medical help or contact a Poison Control Center.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:40.540276 · Updated: 2026-03-14T22:53:33.698024