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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. ​KEEP OUT OF REACH OF CHILDREN.
    9. ​DIRECTIONS
    10. ​OTHER INFORMATION
    11. ​INACTIVE INGREDIENTS
    12. ​ ​QUESTIONS?
    13. RECENT MAJOR CHANGES
    14. ​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 (linea pedis), ringworm (linea corporis) and jock itch (linea cruris)
  • relieves itching, burning and scaling

Warnings



For external use only.


Flammable:



Keep away from heat, sparks, and open flame. Contents under pressure.Do not puncture or incinerate. Do not store at temperature above 120°F.


When Using This Product



  • avoid spraying in eyes
  • use only as directed
  • intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

​Stop Use And Ask A Doctor If



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

​Keep Out Of Reach Of Children.



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


​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
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if conditions 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



SD ALCOHOL 40-B, ETHOXYGLYCOL, PROPYLENE GLYCOL, ACETONE, TOCOPHERYL ACETATE


​ ​Questions?



call 1-866-964-0939


​Principal Display Panel



premier ​

solutions

Antifungal

ATHLETE'S

FOOT

Continuous Liquid Spray

MICONAZOLE NITRATE 2% /

ANTIFUNGAL

CURES MOST
ATHLETE'S FOOT

Relieves itching, scaling & burning

Comforts & refreshes

SPRAYS AT ANY ANGLE

NET WT. 5.3 OZ. (150g)


* Please review the disclaimer below.