Antifungal

Antifungal
SPL v3
SPL
SPL Set ID 8dcca44a-16c7-7262-e053-2a95a90a1b23
Route
TOPICAL
Published
Effective Date 2019-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 mg)
Inactive Ingredients
Dmdm Hydantoin Glyceryl Monostearate Isopropyl Palmitate Peg-100 Stearate Stearic Acid Aloe Vera Leaf Propylene Glycol Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Butylated Hydroxytoluene Cetyl Alcohol Glycerin Water Dimethicone Trolamine Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-25
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Do not use

  • on children under 2 years of age
  • for diaper rash.

For external use only.

Avoid contact with eyes.

Indications and Usage

Uses

Treats most jock itch, ringworm and athlete’s foot

Dosage and Administration

Directions

  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician.
  • Supervise children in the use of this product.

Athlete’s foot

  • Pay special attention to the spaces between toes
  • wear well-fitting, ventilated shoes and change shoes and socks at least once daily

Athlete’s foot and ringworm

  • use daily for 4 weeks

Jock Itch

  • use daily for 2 weeks.

If condition persists longer, consult a doctor.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Consult a Doctor

If irritation occurs or if there is no improvement within 4 weeks for athlete’s foot or ringworm,

or within 2 weeks for jock itch.

Section 51727-6

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, BHT, Cetyl Alcohol, Dimethicone,

DMDM Hydantoin, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate,Iodopropynyl Butylcarbamate,

Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine (may contain Citric Acid).

Section 51945-4

NDC 68599-1471-4

McKesson

Antifungal Cream 2%

MICONAZOLE

NITRATE

Relieves itching, cracking, scaling and

discomfort associated with most jock itch,

ringworm and athlete’s foot.

4 fl oz

(118.3 mL)

MFR # 53-6391

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active ingredient

Miconazole Nitrate 2%

Section 60561-8

Other Information

  • This product is not effective on scalp or nails.
  • Store at 59-86ºF (15-30ºC).

Structured Label Content

Indications and Usage (34067-9)

Uses

Treats most jock itch, ringworm and athlete’s foot

Dosage and Administration (34068-7)

Directions

  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of product over affected area twice daily (morning and night), or as directed by a physician.
  • Supervise children in the use of this product.

Athlete’s foot

  • Pay special attention to the spaces between toes
  • wear well-fitting, ventilated shoes and change shoes and socks at least once daily

Athlete’s foot and ringworm

  • use daily for 4 weeks

Jock Itch

  • use daily for 2 weeks.

If condition persists longer, consult a doctor.

Warnings and Precautions (34071-1)

Warnings

Do not use

  • on children under 2 years of age
  • for diaper rash.

For external use only.

Avoid contact with eyes.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Consult a Doctor

If irritation occurs or if there is no improvement within 4 weeks for athlete’s foot or ringworm,

or within 2 weeks for jock itch.

Section 51727-6 (51727-6)

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, BHT, Cetyl Alcohol, Dimethicone,

DMDM Hydantoin, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate,Iodopropynyl Butylcarbamate,

Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine (may contain Citric Acid).

Section 51945-4 (51945-4)

NDC 68599-1471-4

McKesson

Antifungal Cream 2%

MICONAZOLE

NITRATE

Relieves itching, cracking, scaling and

discomfort associated with most jock itch,

ringworm and athlete’s foot.

4 fl oz

(118.3 mL)

MFR # 53-6391

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active ingredient

Miconazole Nitrate 2%

Section 60561-8 (60561-8)

Other Information

  • This product is not effective on scalp or nails.
  • Store at 59-86ºF (15-30ºC).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:44.986961 · Updated: 2026-03-14T23:03:58.855522