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Miconazole Nitrate Cream USP


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient

Miconazole nitrate USP 2%


Purpose

Antifungal


Uses

  • effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions

Warnings

For external use only


OTC - DO NOT USE SECTION

Do not use on children less than 2 years of age unless directed by a doctor


OTC - WHEN USING SECTION

When using this product avoid contact with eyes


Stop use and ask a doctor if

  • irritation occurs
  • condition persists
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

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 right away (1-800-222-1222).


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
  • not effective on the scalp or nails

Other information

  • do not use if the seal on tube is punctured or not visible
  • To open: unscrew cap, use pointed end on cap to puncture seal
  • store at 20° - 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water


Questions?

Call 1-866-923-4914


SPL UNCLASSIFIED SECTION

Distributed by: RUGBY LABORATORIES17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152