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Novana All-In-One One Step Perineal

Dosage form: lotion
Ingredients: Dimethicone .02mL in 1mL
Labeler: NOVANA MEDICAL LLC
NDC Code: 76077-500

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 Temporarily protects and helps relieve chapped or cracked skin.

Warnings
For external use only.
When using this product • Avoid contact with eyes • Stop use and ask doctor if  • 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.

For external use only.

Directions •Apply as needed. • Change wet and soiled undergarments. • Apply to affected area and gently wipe with clean, soft cloth. • Use with each undergarment change, especially at bedtime or any time when exposure to wet garments may be prolonged.

Inactive ingredients
Water, Cetyl Alcohol, Stearyl Alcohol, Glycine Soja (Soybean) Oil, Propanediol, Polysorbate 60,
Panthenol, Glycerin, Isopropyl Myristate, Allantoin, Tocopherol, Sodium Laureth Sulfate, Citric Acid,
Phenoxyethanol, Iodopropynyl Butylcarbamate

NOVANA ALL-IN-ONE ONE STEP PERINEAL 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76077-500
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 
Cetyl Alcohol 
Stearyl Alcohol 
Soybean Oil 
Propanediol 
Polysorbate 60 
Panthenol 
Glycerin 
Isopropyl Myristate 
Allantoin 
Tocopherol 
Sodium Laureth Sulfate 
CITRIC ACID MONOHYDRATE 
Phenoxyethanol 
Iodopropynyl Butylcarbamate 
Packaging
#Item CodePackage Description
1NDC:76077-500-08240 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/04/2012
Labeler - NOVANA MEDICAL LLC (964916600)
Registrant - O.L. PRODUCTS, INC. (961405883)
Establishment
NameAddressID/FEIOperations
O.L. PRODUCTS, INC. 961405883label, manufacture

Revised: 04/2012
Document Id: c0b20660-4e87-4171-9c70-b6192b224f2c
Set id: 8369a529-5e7c-45af-ab9a-362b8a16f57d
Version: 3
Effective Time: 20120404
 
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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