Otc - Active Ingredient
Active ingredient Purpose
Miconazole Nitrate 2%..............Antifungal
Novana Antifungal Barrier With Miconazole
FDA Label NDC 76077-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Novana Medical, Llc for the product Novana Antifungal Barrier With Miconazole (NDC 76077-400). 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 otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Indications •For effective treatment of athlete's foot (dermatophytosis), jock itch (tinea cruris), and ringworm (tinea corporis). • For the relief of burning, redness, irritation, discomfort, itching, scaling, and cracking.
Warnings
Warnings
For external use only.
Do not use on children under 2 years of age unless directed by a doctor. • Avoid contact with the eyes • If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Directions • Clean 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 athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's 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.
Dosage & Administration
Use Daily for 2 weeks.
If condition persists, consult a doctor. This product is not effective on scalp or nails.
Inactive Ingredient
Inactive ingredients
Cetyl Alcohol,Cod Liver Oil, Diazolidinyl Urea, Dimethicone, Glyceryl Stearate, Lanolin Oil, Methylparaben, Petrolatum, Propanediol, Propylene Glycol, Propylparaben, Sodium Laureth Sulfate, Water, Zinc Oxide
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