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  5. Label Information: Miconole

FDA Label for Miconole

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. OTHER INGREDIENTS:
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. COMMENTS
    11. PRINCIPAL DISPLAY PANEL

Miconole Product Label

The following document was submitted to the FDA by the labeler of this product Option Labs. 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.

Drug Facts



Miconazole Nitrate 2%

Aloe Vera Polysaccharide 1%


Purpose



Antifungal


Other Ingredients:



Allantoin, Cetyl Alcohol, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purified Water, Sodium Hydroxide, Stearic Acid, Fragrance


Uses



for the treatment of

  • athletes foot (tinea pedis)
  • jock itch (tinea cruris)
  • ringworm (tinea corporis)
  • superficial skin infections caused by yeast (candida albicans)

Warnings



for external use only


Otc - Do Not Use



  • do not use on children under 2 years of age unless directed by a doctor
  • avoid contact with eyes
  • If irritation occurs or if there is no improvement within 2 weeks, discontinue use and see a doctor

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
  • apply 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 ringworm use daily for 4 weeks, if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails.

Other Information



Store at 20°C - 25°C (68°F - 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).  See USP Controlled Room Temperature.


Comments



You may report side effects to FDA at 1-800-FDA-1088


Principal Display Panel



Miconole Label - MM1

Miconole Label - MM1

NDC 43645-112-45

Manufactured for:

Option Labs.

801 Noble St., 8th Floor Commerce Tower

Anniston, AL 36201

Miconole

(miconazole nitrate 2%) Cream

with Aloe Vera (proprietary patented

polysaccharides from heart of aloe)

Net Wt. 1.5 oz.

Rev. 02/13


* Please review the disclaimer below.