Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID bed775be-8bcb-44c2-9b9f-8bb25b4b2453
Route
TOPICAL
Published
Effective Date 2023-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (20 mg)
Inactive Ingredients
Cetostearyl Alcohol Chlorocresol Mineral Oil Polyoxyl 20 Cetostearyl Ether Propylene Glycol Water White Petrolatum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-01

Description

Miconazole Nitrate 2%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Miconazole Nitrate 2%

Uses
  • Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm.
  • For effective relief of itching, scaling, burning and discomfort
Section 51945-4

Warnings

For external use only.

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

When using this productavoide contact with eyes

Stop use and ask doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)
Directions
  • wash 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 persists longer, consult a doctor
  • not effective on the scalp or nails
Active Ingredient

Miconazole Nitrate 2%

Inactive Ingredients

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

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 (1-800-222-1222).


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, burning and discomfort
Section 51945-4 (51945-4)

Purpose

Antifungal

Warnings

For external use only.

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

When using this productavoide contact with eyes

Stop use and ask doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)
Directions
  • wash 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 persists longer, consult a doctor
  • not effective on the scalp or nails
Active Ingredient

Miconazole Nitrate 2%

Inactive Ingredients

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, White Petrolatum

Keep Out of Reach of Children (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 (1-800-222-1222).


Advanced Ingredient Data


Raw Label Data

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