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Miconazole Nitrate


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient

Miconazole nitrate USP, 2%


Purpose

Antifungal


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


OTC - DO NOT USE SECTION

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


OTC - WHEN USING SECTION

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)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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


SPL UNCLASSIFIED SECTION

Distributed by: H2-Pharma, LLCMontgomery, AL 36117

Relabeled By: Preferred Pharmaceuticals Inc.