Update-85398-024-01

Update-85398-024-01
SPL v2
SPL
SPL Set ID 4805462b-aec6-78fe-e063-6394a90ae066
Route
TOPICAL
Published
Effective Date 2026-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Borneol Chlorhexidine Acetate Mineral Oil Menthol Phellodendron Amurense Bark Water Dimethicone Zanthoxylum Bungeanum Fruit Viola Philippica Whole Murraya Paniculata Leafy Twig Sophora Flavescens Root Stemona Sessilifolia Root Gleditsia Sinensis Thorn Euphorbia Hirta Smilax Glabra Whole Ophiopogon Japonicus Root Dictamnus Dasycarpus Root Bark Glycerin Petrolatum Cnidium Monnieri Fruit Bassia Scoparia Fruit Glyceryl Monostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-24
Description

Miconazole Nitrate 2%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage
  • Clean the affected area with soap & warm water & dry thoroughly.
  • Apply a thin layer over the affected areatwice daily (morning and night), or asdirected by a doctor.
  • Supervise childrenin the use of the product.
  • For jock itch& psoriasis, use daily for 2 weeks. Forringworm and athlete's foot, use daily for 4 weeks.
  • If the condition persists longer, consult a doctor.
  • This productis not effective on the scalp or nails.
Dosage and Administration
  • Cures most athlete's foot, jock itch, and ringworm.
  • Relieves itching, burning, cracking, scaling & discomfort which accompany these conditions.
Description

Miconazole Nitrate 2%

Section 34078-6

[email protected]

Section 50565-1
  • Keep this and all drugs out of reach of children.
  • If swallowed, get medical help or contacta Poison Control Center right away.
Section 50567-7

avoid contact with eyes.

Section 50569-3
  • Irritation occurs
  • There is no improvementwithin 4 weeks (for athlete's foot andringworm) or 2 weeks (for jock itch).
  • Do not use for diaper rash.
Section 50570-1

on children under 2 years of age except under the advice and supervision of a doctor.

Section 51727-6

Water, Dimethicone, Mineral Oil, Petrolatum,Glycerin, Glyceryl Monostearate, Menthol,Zanthoxylum Bungeanum Fruit Extract,Viola Yedoensis Extract, Euphorbia Hirta Extract, Murraya Paniculata Leaf Extract,Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Smilax Glabra Root Extract, Ophiopogon Japonicus Root Extract, Phellodendron AmurenseBark Extract, Gleditsia Sinensis Thorn Extract, Stemona Sessilifolia Root Extract, Borneol, Chlorhexidine Acetate, Dictamnus Dasycarpus Root Bark Extract, Kochia Scoparia Fruit Extract.

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

Miconazole Nitrate 2%

Section 60561-8
  • Store at 20-Cto 25C(68Fto 77eF).
  • Close the cap tightly after use.

Structured Label Content

Indications and Usage (34067-9)
  • Clean the affected area with soap & warm water & dry thoroughly.
  • Apply a thin layer over the affected areatwice daily (morning and night), or asdirected by a doctor.
  • Supervise childrenin the use of the product.
  • For jock itch& psoriasis, use daily for 2 weeks. Forringworm and athlete's foot, use daily for 4 weeks.
  • If the condition persists longer, consult a doctor.
  • This productis not effective on the scalp or nails.
Dosage and Administration (34068-7)
  • Cures most athlete's foot, jock itch, and ringworm.
  • Relieves itching, burning, cracking, scaling & discomfort which accompany these conditions.
Warnings and Precautions (34071-1)

For external use only.

Section 34078-6 (34078-6)

[email protected]

Section 50565-1 (50565-1)
  • Keep this and all drugs out of reach of children.
  • If swallowed, get medical help or contacta Poison Control Center right away.
Section 50567-7 (50567-7)

avoid contact with eyes.

Section 50569-3 (50569-3)
  • Irritation occurs
  • There is no improvementwithin 4 weeks (for athlete's foot andringworm) or 2 weeks (for jock itch).
  • Do not use for diaper rash.
Section 50570-1 (50570-1)

on children under 2 years of age except under the advice and supervision of a doctor.

Section 51727-6 (51727-6)

Water, Dimethicone, Mineral Oil, Petrolatum,Glycerin, Glyceryl Monostearate, Menthol,Zanthoxylum Bungeanum Fruit Extract,Viola Yedoensis Extract, Euphorbia Hirta Extract, Murraya Paniculata Leaf Extract,Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Smilax Glabra Root Extract, Ophiopogon Japonicus Root Extract, Phellodendron AmurenseBark Extract, Gleditsia Sinensis Thorn Extract, Stemona Sessilifolia Root Extract, Borneol, Chlorhexidine Acetate, Dictamnus Dasycarpus Root Bark Extract, Kochia Scoparia Fruit Extract.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Miconazole Nitrate 2%

Section 60561-8 (60561-8)
  • Store at 20-Cto 25C(68Fto 77eF).
  • Close the cap tightly after use.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:21.200673 · Updated: 2026-03-14T23:14:03.597898