NOVANA PROTECT BARRIER- zinc oxide cream

Novana Protect Barrier by

Drug Labeling and Warnings

Novana Protect Barrier 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
Zinc Oxide 12%...............................Skin Protectant

WARNINGS AND PRECAUTIONS

Warnings

For external use only.

When using this product Do not get in eyes. Stop use and ask doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days. Do not use on deep or puncture wounds animal bites serious burns

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INSTRUCTIONS FOR USE

Directions  Apply as needed

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NOVANA PROTECT BARRIER 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76077-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	.12 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76077-300-04	120 mL in 1 TUBE
2	NDC: 76077-300-07	210 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/04/2012

Labeler - NOVANA MEDICAL LLC (964916600)

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

Establishment
Name	Address	ID/FEI	Business Operations
O.L. PRODUCTS, INC.		961405883	label, manufacture