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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. INACTIVE INGREDIENT
    11. QUESTIONS?
    12. PRINCIPAL DISPLAY PANEL

Miconazole Nitrate Product Label

The following document was submitted to the FDA by the labeler of this product American Sales Company. 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 jock itch (tinea cruris)
  • relieves symptoms of jock itch including itching, burning and chafing associated with jock itch

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.


When Using This Product



  • do not get into eyes or mouth
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

Stop Use And Ask A Doctor If



  • irritation occurs
  • no improvement within 2 weeks for jock itch

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age. Do not use for diaper rash. Do not use on children under 2 years of age unless directed by a doctor.


Directions



  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • use daily for 2 weeks. If conditions persist, consult a doctor
  • this product is not effective on scalp or nails
  • in case of clogging, clear nozzle under running water

Inactive Ingredient



Disteardimonium Hectorite, Isobutane, Kaolin, SD Alcohol 40-B, Zea Mays (Corn) Starch


Questions?



Call 1-866-964-0939


Principal Display Panel



CareOne

ANTIFUNGAL

JOCK ITCH

POWDER SPRAY

MICONAZOLE NITRATE 2%

CURES MOST JOCK ITCH

RELIEVES ITCHING, CHAFING, AND BURNING

TALC- FREE

NET WT 4.6 OZ (130 g)


* Please review the disclaimer below.