FDA Label for Miconazole Nitrate

Active Ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

• treats most athlete’s foot, jock itch and ringworm
• relieves itching, scaling, burning, irritation and discomfort

Warnings

For external use only

When Using This Product

• do not get into the eyes

Stop Use And Ask A Doctor If

• irritation occurs
• there is no improvement within 4 weeks (for athlete’s foot or ringworm) or within 2 weeks (for jock itch)

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

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

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
• this product does not work on the scalp or nails

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 every day

  For athlete’s foot and ringworm

• use every day for 4 weeks

  For jock itch

• use every day for 2 weeks. If condition lasts longer, contact a doctor.

Other Information

Store at room temperature 59° - 86°F (15° - 30°C).

IMPORTANT: The opening of this product is covered by a metal tamper-evident seal. If this seal has been punctured or is not visible, do not use and return product to place of purchase.

TO OPEN: To puncture the seal, reverse the cap and place the puncture-top onto the tube. Push firmly until seal is open. To close, screw the cap back onto the tube.

Inactive Ingredients

Benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Package Label.Principal Display Panel

NDC 54868-2471-0

image of package label - 2471