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  5. Label Information: Miconazole

FDA Label for Miconazole

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. USES - ANTIFUNGAL
    3. WARNINGS
    4. DIRECTIONS
    5. OTHER INFORMATION.
    6. INACTIVE INGREDIENTS
    7. KEEP OUT OF REACH OF CHILDREN
    8. PRINCIPAL DISPLAY PANEL

Miconazole Product Label

The following document was submitted to the FDA by the labeler of this product Galentic Pharma (india) Priva Te Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.
    • 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.

Other Information.



Protect from freezing. Avoid excessive heat.


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


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