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  5. Label Information: Novana Antifungal Barrier With Miconazole

FDA Label for Novana Antifungal Barrier With Miconazole

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. INDICATIONS & USAGE
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT

Novana Antifungal Barrier With Miconazole Product Label

The following document was submitted to the FDA by the labeler of this product Novana Medical, 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.

Otc - Active Ingredient



Active ingredient                       Purpose
Miconazole Nitrate 2%..............Antifungal


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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