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Kaiser Permanente

KAISER FOUNDATION HOSPITALS
Taro Pharmaceuticals U.S.A., Inc.

Kaiser Permanente Miconazole Nitrate


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Miconazole nitrate USP 2%

Purpose

Antifungal

Kaiser Permanente 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

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

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.

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

Kaiser Permanente Other information

  • 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

Manufactured by
Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1

Distributed by
Kaiser Foundation Hospitals
Livermore, CA 94551-9756

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

KAISER PERMANENTE ®

Miconazole Nitrate Cream USP, 2%

ANTIFUNGAL CREAM
CURES MOST ATHLETE'S FOOT

*Compare to the active ingredient in Micatin ®

NET WT 1 OZ (30 g)

Kaiser Permanente

Kaiser Permanente

Miconazole Nitrate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0179-8017
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
Apricot Kernel Oil
BENZOIC ACID
BUTYLATED HYDROXYTOLUENE
GLYCOL STEARATE
Mineral Oil
POLYETHYLENE GLYCOL 300
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 TUBE
2 NDC:0179-8017-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 1991-10-01


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Be sure to consult your doctor before taking any medication!
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