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

Purpose

Antifungal

Description

Miconazole Nitrate 2%


Medication Information

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)
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
Purpose

Antifungal

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
Inactive Ingredients

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

Description

Miconazole Nitrate 2%

Section 51945-4

Active Ingredient

Miconazole Nitrate 2%

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

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)
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
Purpose

Antifungal

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
Inactive Ingredients

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

Section 51945-4 (51945-4)

Active Ingredient

Miconazole Nitrate 2%

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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