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  5. Label Information: Miconazole Nitrate

FDA Label for Miconazole Nitrate

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. PACKAGING

Miconazole Nitrate Product Label

The following document was submitted to the FDA by the labeler of this product Nucare Pharmaceuticals,inc.. 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.

Drug Facts




Active Ingredient



Miconazole Nitrate 2%


Purpose



Anti-Fungal


Uses



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

Warnings



For external use only. Do not use if the safety-sealed tube is punctured or damaged.

Do not use on children under 2 years of age unless directed by a healthcare professional. When using this product avoid contact with the eyes.

• 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).


Directions



• Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professional • Supervise children in the use of this product.

• Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily.

Use daily for 4 weeks. If condition persists, consult a healthcare professional.

For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

This product is not effective on the scalp or nails.


Other Information



• Store at 15° - 30° c (59° - 86° f)• Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.

You may report serious side effects to: [email protected]


Packaging



pdp - 68071 3429 3

pdp - 68071 3429 3


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