Active Ingredient:
Miconazole Nitrate 2%
Dermafungal
FDA Label NDC 61924-234
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermarite Industries, Llc for the product Dermafungal (NDC 61924-234). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient:, purpose:, uses:, warnings:, warnings, directions, other information:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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