FDA Label for Dermafungal

View Indications, Usage & Precautions

Dermafungal Product Label

The following document was submitted to the FDA by the labeler of this product Dermarite Industries, 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.

Active Ingredient:



Miconazole Nitrate 2%


Purpose:



Antifungal


Uses:



  • For the treatment and prevention of most: athlete's foot, jock itch, ringworm
  • relieves itching, scaling,cracking, and discomfort associated with these conditions.

Warnings:



  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Stop use and ask doctor if irritation occurs , condition worsens or does not improve in 2 weeks for jock itch, or within 4 weeks for athlete's foot and ringworm.

Warnings



  • Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.

Directions



Cleanse affected area and dry thoroughly. Apply a thin layer to affected area twice daily or as directed by physician.

  • For jockitch use daily for two weeks.
  • For athelete's foot use daily for four weeks.

Other Information:



  • This product is not effective on the scalp and nails.
  • Store at room temperature (59°-86°F)

Inactive Ingredients:



Caprylic/Capric Triglyceride, Ceteareth-20, Disodium EDTA, Glyceryl Stearate, Methylparaben, PEG-40 Castor Oil, PEG-100 Stearate, Petrolatum, Propylene Glycol, Propylparaben, Stearic Acid, Water, Xantham Gum


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