1236-cs Antifungal Powder (talc Free)

1236-cs Antifungal Powder (talc Free)
SPL v1
SPL
SPL Set ID 312ba573-4008-83e6-e063-6294a90a4a6d
Route
TOPICAL
Published
Effective Date 2025-04-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Starch, Corn Silicon Dioxide Glycyrrhizinate Dipotassium Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-04

Description

Miconazole Nitrate 2% USP

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2% USP

Label

1236-CS Antifungal Powder (Talc Free)

Use(s)

• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), and ringworm (tinea corporis)

• Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch and itching or burning feet.

Warnings

For External Use Only

Directions

• Clean the affected area and dry thoroughly. Apply a thin layer over the 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 daily

• For athlete's foot and ringworm: use daily for 4 weeks

• For jock itch: use daily for 2 weeks

• If condition persists longer, consult a doctor

• 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

• For diaper rash

Questions?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Active Ingredient

Miconazole Nitrate 2% USP

Other Information

• Store at Controlled Room Temperature • Do not use if "Remove before Use" seal is missing

Inactive Ingredients

Colloidal Silicon Dioxide, Corn Starch, Dipotassium Glycyrrhizinate, Sodium Benzoate

When Using This Product

• Avoid contact with the eyes

Ask A Doctor Or Pharmacist

Before use if you are taking anticoagulants such as warfarin

Stop Use and Ask A Doctor If

• Irritation occurs

• There is no improvement within 2 weeks when used for the treatment of jock itch

• There is no improvement within 4 weeks when used for athlete's foot or ringworm

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Label

1236-CS Antifungal Powder (Talc Free)

Use(s)

• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), and ringworm (tinea corporis)

• Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch and itching or burning feet.

Purpose

Antifungal

Warnings

For External Use Only

Directions

• Clean the affected area and dry thoroughly. Apply a thin layer over the 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 daily

• For athlete's foot and ringworm: use daily for 4 weeks

• For jock itch: use daily for 2 weeks

• If condition persists longer, consult a doctor

• 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

• For diaper rash

Questions?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Active Ingredient

Miconazole Nitrate 2% USP

Other Information

• Store at Controlled Room Temperature • Do not use if "Remove before Use" seal is missing

Inactive Ingredients

Colloidal Silicon Dioxide, Corn Starch, Dipotassium Glycyrrhizinate, Sodium Benzoate

When Using This Product (When using this product)

• Avoid contact with the eyes

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

Before use if you are taking anticoagulants such as warfarin

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

• Irritation occurs

• There is no improvement within 2 weeks when used for the treatment of jock itch

• There is no improvement within 4 weeks when used for athlete's foot or ringworm

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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)