Miconazole Nitrate Cream, Usp

Miconazole Nitrate Cream, Usp
SPL v12
SPL
SPL Set ID 246be926-79ea-4e0c-a3ef-2aa7fc3a52bf
Route
TOPICAL
Published
Effective Date 2025-06-30
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 DRUG Active Since 2009-05-15 Until 2026-12-31

Description

Miconazole nitrate, USP 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

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
  • 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 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.

Package Label
PREMIER VALUE Antifungal Cream
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

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENT IN MICARIN® ANTIFUNGAL CREAM*

Antifungal Cream

Miconazole nitrate cream, USP 2%

Cures Most

Athlete's Foot,

Jock Itch & Ringworm.

Soothes Itching, Scaling, Cracking, and Burning

*This product is not manufactured or distributed by WellSpring Pharmaceutical Corporation, distributor of Micatin® Antifungal Cream.

Distributed By: Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

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 (1-800-222-1222) 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
  • 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 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.

Package Label (Package label)
PREMIER VALUE Antifungal Cream
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

Principal Display Panel (Principal display panel)

COMPARE TO THE ACTIVE INGREDIENT IN MICARIN® ANTIFUNGAL CREAM*

Antifungal Cream

Miconazole nitrate cream, USP 2%

Cures Most

Athlete's Foot,

Jock Itch & Ringworm.

Soothes Itching, Scaling, Cracking, and Burning

*This product is not manufactured or distributed by WellSpring Pharmaceutical Corporation, distributor of Micatin® Antifungal Cream.

Distributed By: Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

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 (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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