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.

Drug Facts

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76077-400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate.02 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Cetyl Alcohol 
GLYCERYL MONOSTEARATE 
Petrolatum 
Lanolin 
Cod Liver Oil 
Propanediol 
Sodium Laureth Sulfate 
Propylene Glycol 
Diazolidinyl Urea 
Methylparaben 
Propylparaben 
Zinc Oxide 
Dimethicone 
Packaging
#Item CodePackage Description
1NDC:76077-400-04120 mL in 1 TUBE
2NDC:76077-400-07210 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/04/2012
Labeler - Novana Medical, LLC (964916600)
Registrant - O.L. PRODUCTS, INC. (961405883)
Establishment
NameAddressID/FEIOperations
Novana Medical, LLC964916600label, manufacture

Revised: 04/2012
 
Novana Medical, LLC

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)