Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0482ce9f-c98a-4f37-8b37-6df1738b6da3
Route
TOPICAL
Published
Effective Date 2026-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Caprylic/capric Triglyceride Ceteareth-20 Cetearyl Alcohol Dimethicone Edetate Disodium Glyceryl Stearate Imidazolidinyl Urea Peg-100 Stearate Peg-40 Castor Oil Petrolatum Propylene Glycol Sodium Cetearyl Sulfate Stearic Acid Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-31

Description

Miconazole Nitrate 2%w/w

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%w/w

Uses

Uses

• For the treatment and prevention of most:

• Athlete’s foot

• Jock itch

• Ringworm

• Relieves itching, scaling, cracking, and discomfort associated with these conditions

Warnings

For external use only

Directions

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

For athlete's foot:• Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes •Wear well fitting, ventilated shoes • Change socks atleast once daily.

For ringworm:Use daily for 4 weeks. If condition persists, consult a healthcare professional.

For jock itch:Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

This product is not effective on the scalp or nails.

Do Not Use

on children under 2 years of age unless directed by a doctor

Other Information

• Store between 15-30°C (59-86°F)

Inactive Ingredients

Caprylic/capric triglyceride, Cetereath-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Water, Xanthum Gum

Principal Display Panel

Elixir

Elixir MycoTender

Miconazole Nitrate

Antifungal Cream

With 2% Micronazole

Nitrate

CURSE JOCK ITCH &

RING WORM SOOTHES

AND PROMOTES HEALING

4 Oz. (113) g

When Using This Product

Avoid contact with eyes

Stop Use and Ask A Doctor If

• condition persists or gets worse

• a rash or other allergic reaction develops

Keep Out of Reach of Children

In case of accidental ingestion contact a physician or Poison Control Center right away and discomfort which accompany these conditions

Active Ingredient (in Each Gram)

Miconazole Nitrate 2%w/w


Structured Label Content

Uses

Uses

• For the treatment and prevention of most:

• Athlete’s foot

• Jock itch

• Ringworm

• Relieves itching, scaling, cracking, and discomfort associated with these conditions

Purpose

Antifungal

Warnings

For external use only

Directions

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

For athlete's foot:• Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes •Wear well fitting, ventilated shoes • Change socks atleast once daily.

For ringworm:Use daily for 4 weeks. If condition persists, consult a healthcare professional.

For jock itch:Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

This product is not effective on the scalp or nails.

Do Not Use (Do not use)

on children under 2 years of age unless directed by a doctor

Other Information (Other information)

• Store between 15-30°C (59-86°F)

Inactive Ingredients (Inactive ingredients)

Caprylic/capric triglyceride, Cetereath-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Water, Xanthum Gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Elixir

Elixir MycoTender

Miconazole Nitrate

Antifungal Cream

With 2% Micronazole

Nitrate

CURSE JOCK ITCH &

RING WORM SOOTHES

AND PROMOTES HEALING

4 Oz. (113) g

When Using This Product (When using this product)

Avoid contact with eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• condition persists or gets worse

• a rash or other allergic reaction develops

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion contact a physician or Poison Control Center right away and discomfort which accompany these conditions

Active Ingredient (in Each Gram) (Active Ingredient (in each gram))

Miconazole Nitrate 2%w/w


Advanced Ingredient Data


Raw Label Data

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