NOVANA ANTIFUNGAL BARRIER WITH MICONAZOLE- miconazole nitrate cream

Novana Antifungal Barrier with Miconazole by

Drug Labeling and Warnings

Novana Antifungal Barrier with Miconazole by is a Otc medication manufactured, distributed, or labeled by Novana Medical, LLC, O.L. PRODUCTS, INC. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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.

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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NOVANA ANTIFUNGAL BARRIER WITH MICONAZOLE 
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76077-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M)	Miconazole Nitrate	.02 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetyl Alcohol (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Petrolatum (UNII: 4T6H12BN9U)
Lanolin (UNII: 7EV65EAW6H)
Cod Liver Oil (UNII: BBL281NWFG)
Propanediol (UNII: 5965N8W85T)
Sodium Laureth Sulfate (UNII: BPV390UAP0)
Propylene Glycol (UNII: 6DC9Q167V3)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Zinc Oxide (UNII: SOI2LOH54Z)
Dimethicone (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76077-400-04	120 mL in 1 TUBE
2	NDC: 76077-400-07	210 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/04/2012

Labeler - Novana Medical, LLC (964916600)

Registrant - O.L. PRODUCTS, INC. (961405883)

Establishment
Name	Address	ID/FEI	Business Operations
Novana Medical, LLC		964916600	label, manufacture