1. Home
  2. Labeler Index
  3. Westminster Pharmaceuticals, Llc
  4. 69367-399
  5. Label Information: Miconazole Nitrate

FDA Label for Miconazole Nitrate

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PRINCIPAL DISPLAY PANEL - 85 G BOTTLE LABEL

Miconazole Nitrate Product Label

The following document was submitted to the FDA by the labeler of this product Westminster Pharmaceuticals, Llc. 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.

Other



Drug Facts


Active Ingredient



Miconazole Nitrate 2.0%


Purpose



Antifungul


Uses



  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • for the treatment of most superficial skin infections caused by yeast (candida albicans)
  • relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Warnings



  • for external use only

Do Not Use



  • on children under 2 years of age unless by a doctor
  • avoid contact with the eyes
  • for athlete's foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
  • for jock itch - if irritation occurs, or if there is no improvement within 2 weeks, dicontinue use and consult a doctor

Otc - 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.


Directions



  • clean the affected area and dry thoroughly
  • apply a thin layer of powder 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
  • for athletes 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 the scalp or nails

Other Information



  • protect from freezing. Avoid excessive heat.
  • do not use if package is damaged

Inactive Ingredients



allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalcium phosphate, corn starch


Principal Display Panel - 85 G Bottle Label



NDC 69367-399-85

Miconazole

Antifungul Powder
Treatment

Miconazole Nitrate 2%

Botanical Nutrition For
Sensitive Skin

* Please review the disclaimer below.