FDA Label for Miconazole Nitrate

View Indications, Usage & Precautions

Miconazole Nitrate Product Label

The following document was submitted to the FDA by the labeler of this product Harmon Store 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 itching, burning and scaling

Warnings



For external use only.


Extremely Flammable:



Content under pressure. Keep away from fire, sparks and heated surfaces. Do not punchure or incinerate container. Exposure to temperatures above 120 oF may cause bursting. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.


Do Not Use



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


When Using This Product



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

Stop Use And Ask A Doctor If



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

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



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

Other Information



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


Inactive Ingredients



acetone, ethoxydiglycol, propylene glycol, SD alcohol 40-B (74%w/w), tocopheryl acetate


Questions?



Call 1-866-964-0939


Principal Display Panel



CoreValues

Athlete's Foot

Antifungal

Liquid Spray

Miconazole Nitrate 2%

  • Cure Most Athlete's Foot
  • Relieves itching, scaling and burning.
  • Net WT 5.3OZ (150g)


* Please review the disclaimer below.