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  5. Label Information: Miconazole Nitrate

FDA Label for Miconazole Nitrate

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. FLAMMABLE:
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. DO NOT USE
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. RECENT MAJOR CHANGES
    15. PRINCIPAL DISPLAY PANEL

Miconazole Nitrate Product Label

The following document was submitted to the FDA by the labeler of this product Premier Brands Of America 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%


Purpose



Antifungal


Uses



  • cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
  • relieves symptoms of athlete's foot, including itching, burning and cracking

Warnings



For external use only.


Flammable:



Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.


When Using This Product



  • avoid contact with the eyes or mouth
  • use only as directed

Stop Use And Ask A Doctor If



  • irritation occurs
  • no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

Do Not Use



on children under 2 years of age unless directed by a doctor.


Directions



  • wash the affected area and dry thoroughly
  • shake can well and spray 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
  • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch; if conditions persist, consult a doctor
  • this product is not effective on the scalp or nails
  • if nozzle clogs, clean with a pin

Other Information



  • store between 20° and 30°C (68° and 86°F)

Inactive Ingredients



DISTEARDIMONIUM HECTORITE, ISOBUTANE, KAOLIN, SD ALCOHOL 40-B, ZEA MAYS (CORN) STARCH,


Questions?



Call 1-866-964-0939


Principal Display Panel



Soothing

Feet!

"Your Daily Foot Spa"

In a Can

Antifungal

Powder Spray

Miconazole Nitrate 2%

Cures most athlete's foot

Relieves itching,cracking

& burning

Talc- free

NET WT 4.6 OZ. (130 g)


* Please review the disclaimer below.