Novana Moisturizing

Dosage form: cream
Ingredients: Dimethicone .02mL in 1mL
Labeler: NOVANA MEDICAL LLC
NDC Code: 76077-200

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
Dimethicone 2%...................Skin Protectant


Uses Helps to prevent and temporarily protect chafed, chapped, or cracked skin.

Warnings
When using this product • Do not get into 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.

For external use only.

Inactive ingredients
Water, Lanolin Oil, Cod Liver Oil, Propylene Glycol, Polyethylene, Sodium Polyacrylate, Cetyl Alcohol, Beeswax, Glyceryl Stearate, Caprylic/Capric Triglyceride, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Sodium Laureth Sulfate, Diazolidinyl Urea, Methylparaben, Propylparaben, Fragrance.

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.

NOVANA MOISTURIZING 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76077-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone.02 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Lanolin 
Cod Liver Oil 
Propylene Glycol 
HIGH DENSITY POLYETHYLENE 
SODIUM POLYACRYLATE (2500000 MW) 
Cetyl Alcohol 
YELLOW WAX 
Glyceryl Monostearate 
MEDIUM-CHAIN TRIGLYCERIDES 
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) 
Sodium Laureth Sulfate 
Diazolidinyl Urea 
Methylparaben 
Propylparaben 
Packaging
#Item CodePackage Description
1NDC:76077-200-04120 mL in 1 TUBE
2NDC:76077-200-07210 mL in 1 TUBE
3NDC:76077-200-09270 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/04/2012
Labeler - NOVANA MEDICAL LLC (964916600)
Registrant - O.L. PRODUCTS, INC. (961405883)
Establishment
NameAddressID/FEIOperations
O.L. PRODUCTS, INC. 961405883label, 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.

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