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

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Miconazole Nitrate

Taro Pharmaceuticals U.S.A., Inc.

Miconazole Nitrate


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Miconazole nitrate USP 2%

Purpose

Antifungal

Miconazole Nitrate 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

Miconazole Nitrate 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

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.

Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Cures Most Athlete's Foot

Antifungal Cream

Miconazole Nitrate
Cream USP, 2%
Antifungal Cream

NET WT 1/2 oz (15 g)

Miconazole Nitrate

Miconazole Nitrate

Miconazole Nitrate CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51672-2001
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
PEG-6 STEARATE
PEG-32 stearate

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 TUBE
2 30 in 1 TUBE
3 NDC:51672-2001-2 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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