Miconazole Nitrate description, usages, side effects, indications, overdosage, supplying and lots more!

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Miconazole Nitrate

Qualitest Pharmaceuticals

Miconazole Nitrate 2% Cream


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Miconazole nitrate 2%

Antifungal

  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, scaling, cracking, burning and discomfort associated with those conditions

For external use only

Do not use

on children under 2 years of age unless directed by a doctor

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

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

Keep out of reach of children.

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

  • 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:

  • use daily for 4 weeks. If condition persists longer, consult a doctor.
  • pay special attention to the spaces between the toes
  • wear well-fitting, ventilated shoes
  • change shoes and socks at least once daily

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

  • store at 15° - 30°C (59° - 86°F)
  • lot number and expiration date: see crimp of tube or see box
  • to open: unscrew cap, use pointed end on cap to puncture seal

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 10/09 R2
8280719 7805

PRINCIPAL DISPLAY PANEL

Miconazole Nitrate

Miconazole Nitrate

miconazole nitrate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0603-7805
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MICONAZOLE NITRATE MICONAZOLE 20 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
Mineral Oil
PEG-5 OLEATE
PEGOXOL 7 STEARATE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28.4 in 1 TUBE
2 NDC:0603-7805-50 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2003-09-01


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Be sure to consult your doctor before taking any medication!
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