miconazole nitrate cream, usp

miconazole nitrate cream, usp
SPL v7
SPL
SPL Set ID 197ee41f-4faa-4251-8c86-1669d5e0b443
Route
topical
Published
Effective Date 2021-02-09
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

Purpose

Antifungal

How Supplied

Product: 50090-2718 NDC: 50090-2718-0 28 g in a TUBE / 1 in a CARTON

Description

Miconazole nitrate, USP 2%


Medication Information

Warnings

For external use only

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

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
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.
Inactive Ingredients

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

How Supplied

Product: 50090-2718

NDC: 50090-2718-0 28 g in a TUBE / 1 in a CARTON

Description

Miconazole nitrate, USP 2%

Questions?

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

Do Not Use

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

Active Ingredient

Miconazole nitrate, USP 2%

Miconazole Nitrate
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

Warnings

For external use only

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

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
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.
Inactive Ingredients (Inactive ingredients)

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

How Supplied (HOW SUPPLIED)

Product: 50090-2718

NDC: 50090-2718-0 28 g in a TUBE / 1 in a CARTON

Questions?

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

Do Not Use (Do not use)

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

Active Ingredient (Active ingredient)

Miconazole nitrate, USP 2%

Miconazole Nitrate (miconazole nitrate)
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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