Anti-fungal Cream

Anti-fungal Cream
SPL v1
SPL
SPL Set ID b6599a9c-04d5-e214-e053-2995a90ac95d
Route
TOPICAL
Published
Effective Date 2020-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (0.02 g)
Inactive Ingredients
Water Cetostearyl Alcohol Ceteth-20 Mineral Oil Petrolatum Propylene Glycol Sodium Phosphate Chlorocresol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-12-09
Description

Active Ingredient Miconazole Nitrate 2%

Medication Information

Warnings and Precautions

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

For external use only.

Indications and Usage

Uses

  • cures most athlete's foot, jock itch, and ringworm.
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
Dosage and Administration

Directions

  • wash affected area and dry thoroughly

  • Apply a thin layer 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 a day

  • for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks

  • if conditions persist longer, ask a doctor

  • this product is not effective on the scalp or nails.

Description

Active Ingredient Miconazole Nitrate 2%

Section 42229-5

Other information

  • Store between 20ºC to 25º C (68ºF to 77º F)
  • Lot No. & Exp. Date: see crimp of tube.
Section 50565-1

Keep this and all drugs out of reach of children.

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

Section 50566-9

Stop using this product and ask a doctor

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch).
  • do not use for diaper rash
Section 50567-7

When using this product avoid contact with eyes.

Section 51727-6

Inactive Ingredients

Purified water, cetostearyl alcohol, cetomacrogol-1000, mineral oil, petrolatum, propyleneglycol, sodium phosphate, chlorocresol.

Section 51945-4

PRINCIPAL DISPLAY PANEL

Anti-Fungal Cream

NET WT 0.5 OZ (14 g)

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active Ingredient

Miconazole Nitrate 2%

Structured Label Content

Indications and Usage (34067-9)

Uses

  • cures most athlete's foot, jock itch, and ringworm.
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
Dosage and Administration (34068-7)

Directions

  • wash affected area and dry thoroughly

  • Apply a thin layer 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 a day

  • for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks

  • if conditions persist longer, ask a doctor

  • this product is not effective on the scalp or nails.

Warnings and Precautions (34071-1)

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

For external use only.

Section 42229-5 (42229-5)

Other information

  • Store between 20ºC to 25º C (68ºF to 77º F)
  • Lot No. & Exp. Date: see crimp of tube.
Section 50565-1 (50565-1)

Keep this and all drugs out of reach of children.

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

Section 50566-9 (50566-9)

Stop using this product and ask a doctor

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot and ringworm) or 2 weeks (for jock itch).
  • do not use for diaper rash
Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

Section 51727-6 (51727-6)

Inactive Ingredients

Purified water, cetostearyl alcohol, cetomacrogol-1000, mineral oil, petrolatum, propyleneglycol, sodium phosphate, chlorocresol.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

Anti-Fungal Cream

NET WT 0.5 OZ (14 g)

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active Ingredient

Miconazole Nitrate 2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:09.609910 · Updated: 2026-03-14T22:59:02.436223