Miconazole Nitrate Cream, Usp

Miconazole Nitrate Cream, Usp
SPL v10
SPL
SPL Set ID c3637989-42e9-479b-a343-d661f9b104a9
Route
TOPICAL
Published
Effective Date 2021-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Benzoic Acid Butylated Hydroxyanisole Mineral Oil Pegoxol 7 Stearate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 1997-06-01

Description

Miconazole nitrate, USP 2%

Purpose

Antifungal

How Supplied

Product: 50090-2231 NDC: 50090-2231-0 14 g in a TUBE / 1 in a CARTON


Medication Information

Purpose

Antifungal

How Supplied

Product: 50090-2231

NDC: 50090-2231-0 14 g in a TUBE / 1 in a CARTON

Description

Miconazole nitrate, USP 2%

Uses
  • proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
  • for effective relief of itching, scaling, cracking, burning, and discomfort
Warnings

For external use only

Directions
  • wash 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 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 lasts longer, contact 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.

Questions?

 1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Active Ingredient

Miconazole nitrate, USP 2%

Other Information
  • store at controlled room temperature 59°-86°F (15°-30°C).
  • before using any medication, read all label directions. Keep carton, it contains important information.
Miconazole Nitrate
Inactive Ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

When Using This Product
  • avoid contact with the eyes
Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm
  • for effective relief of itching, scaling, cracking, burning, and discomfort
Purpose

Antifungal

Warnings

For external use only

Directions
  • wash 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 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 lasts longer, contact 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.

Questions?

 1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

How Supplied (HOW SUPPLIED)

Product: 50090-2231

NDC: 50090-2231-0 14 g in a TUBE / 1 in a CARTON

Active Ingredient (Active ingredient)

Miconazole nitrate, USP 2%

Other Information (Other information)
  • store at controlled room temperature 59°-86°F (15°-30°C).
  • before using any medication, read all label directions. Keep carton, it contains important information.
Miconazole Nitrate (miconazole nitrate)
Inactive Ingredients (Inactive ingredients)

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

When Using This Product (When using this product)
  • avoid contact with the eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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