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  5. Label Information: Miconazole

FDA Label for Miconazole

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. WARNINGS
    3. OTC - DO NOT USE
    4. OTC - STOP USE
    5. USES
    6. INDICATIONS AND USAGE
    7. OTHER INFORMATION.
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. KEEP OUT OF REACH OF CHILDREN

Miconazole Product Label

The following document was submitted to the FDA by the labeler of this product Kinray, 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.

Active Ingredient



Miconazole Nitrate 2%


Warnings



For External Use Only


Otc - Do Not Use



Do not use

  • on children under 2 years of age unless directed by a doctor.
  • for diaper rash

    • When using this product 

    • avoid contact with eyes

Otc - Stop Use



Stop use and ask a doctor if

  • irritation occurs
  • there is no improvementwithin 2 weeks when used for the treatment of jock itch
  • there is no improvementwithin 4 weeks when used for athletes foot or ringworm

Uses



  • For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch or itching burning feet

Indications And Usage



  • Supervise children in the use of this product.

Other Information.



Store at room temperature


Directions



  • Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 toes: wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • Foe athlete's foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on scalp or nails.

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 right away

* Please review the disclaimer below.