Miconazole Nitrate

Miconazole Nitrate
SPL v6
SPL
SPL Set ID 7a0ef38a-9584-4e67-ba86-c31f86da1ed0
Route
TOPICAL
Published
Effective Date 2023-12-11
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 Apricot Kernel Oil Peg-6 Esters Pegoxol 7 Stearate Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-29

Description

Drug Facts

Purpose

Antifungal

How Supplied

Product: 50090-5607 NDC: 50090-5607-0 14 g in a TUBE / 1 in a CARTON


Medication Information

Purpose

Antifungal

How Supplied

Product: 50090-5607

NDC: 50090-5607-0 14 g in a TUBE / 1 in a CARTON

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product, avoid contact with the eyes.

Section 50570-1

Do not use on children under 2 years of age unless directed by a doctor.

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 doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to the 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
Active Ingredient

Miconazole nitrate USP, 2%

Other Information
  • do not use if foil seal on tube opening is broken or missing
  • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
  • store at room temperature 15°-30°C (59°-86°F)
  • 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

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Miconazole Nitrate Cream
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)

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product, avoid contact with the eyes.

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a doctor.

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 doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to the 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
How Supplied (HOW SUPPLIED)

Product: 50090-5607

NDC: 50090-5607-0 14 g in a TUBE / 1 in a CARTON

Active Ingredient (Active ingredient)

Miconazole nitrate USP, 2%

Other Information (Other information)
  • do not use if foil seal on tube opening is broken or missing
  • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
  • store at room temperature 15°-30°C (59°-86°F)
  • 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

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Miconazole Nitrate Cream (MICONAZOLE NITRATE CREAM)
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)

Advanced Ingredient Data


Raw Label Data

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