Novana Antifungal Barrier with Miconazole
Dosage form: cream
Ingredients: Miconazole Nitrate .02mL in 1mL
Labeler: Novana Medical, LLC
NDC Code: 76077-400
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Active ingredient Purpose
Miconazole Nitrate 2%..............Antifungal
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
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.
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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.
Use Daily for 2 weeks.
If condition persists, consult a doctor. This product is not effective on scalp or nails.
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
| NOVANA ANTIFUNGAL BARRIER WITH MICONAZOLE
miconazole nitrate cream |
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| Labeler - Novana Medical, LLC (964916600) |
| Registrant - O.L. PRODUCTS, INC. (961405883) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Novana Medical, LLC | 964916600 | label, manufacture | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
