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

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MICONAZOLE

Galentic Pharma (India) Priva Te Limited

Antifungal


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Miconazole Nitrate 2%

Uses - Antifungal

  • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
  • For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.

Warnings

Do not use:

  • Do not use on children under 2 years of age unless directed by a doctor.
  • Avoid contact with eyes.
  • For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions



  • Supervise children in the use of this product.
  • If conditions persist longer, consult a doctor.
  • This product is not effective on scalp or nails.

Other information.

Protect from freezing. Avoid excessive heat.

Directions

  • Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
  • Foe athlete's foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks.
  • For athlete's foot, pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

Inactive Ingredients

Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, white soft paraffin.

Keep Out of Reach of Children

  • KEEP OUT OF REACH OF CHILDREN
  • If swallowed get medical help or contact a Poison Control Center.

Principal Display Panel

Principal Display Panel

Miconazole Nitrate Cream USP 2%


Gal Miconazole.jpg

MICONAZOLE

MICONAZOLE

antifungal CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50382-050
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
CETETH-20
CETOSTEARYL ALCOHOL
chlorocresol
LIGHT MINERAL OIL
propylene glycol
water
Mineral Oil

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28.4 in 1 TUBE
2 1 in 1 BOX
3 NDC:50382-050-01 72 in 1 CASE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2013-07-18


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