NOVANA PROTECT BARRIER - zinc oxide cream 
NOVANA MEDICAL LLC

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.

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Drug Facts

Active ingredient                             Purpose
Zinc Oxide 12%...............................Skin Protectant

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.

Directions  • Apply as needed

Inactive ingredients
Cetyl Alcohol,Cod Liver Oil, Diazolidinyl Urea, Dimethicone, Glyceryl Stearate, Lanolin Oil, Methylparaben, Petrolatum, Propanediol, Propylene Glycol, Propylparaben, Sodium Laureth Sulfate, Water


Label of Package

NOVANA PROTECT BARRIER 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76077-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide.12 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76077-300-04120 mL in 1 TUBE
2NDC:76077-300-07210 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/04/2012
Labeler - NOVANA MEDICAL LLC (964916600)
Registrant - O.L. PRODUCTS, INC. (961405883)
Establishment
NameAddressID/FEIBusiness Operations
O.L. PRODUCTS, INC. 961405883label, manufacture

Revised: 4/2012
Document Id: 7dfb8b9c-ad7a-4ba9-bbc9-3e356fd002ae
Set id: c857326a-655c-428d-ab96-a2da492194e6
Version: 3
Effective Time: 20120404
 
NOVANA MEDICAL LLC