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Novana Wash Perineal Skin Cleanser

Medically reviewed on April 4, 2018

Dosage form: solution
Ingredients: Benzethonium Chloride 0.001mL in 1mL
Labeler: NOVANA MEDICAL LLC
NDC Code: 76077-100

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
Benzethonium Chloride 0.1 %......................................................Antiseptic

Uses For skin irritation due to incontinence. Protects against the risk of bacterial contamination in minor cuts, scrapes, and burns. Aids in the cleanup of urine and feces. Helps to remove barrier cream from skin.

Warnings
For external use only.
When using this product
• Do not get into eyes. • If contact occurs, rinse eyes thoroughly with water. Stop use and ask doctor if • if skin irritation and redness develop.



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 Cleanse the affected area according to protocol.

Inactive ingredients Water, Sodium Laureth Sulfate, Polyquaternium-7, Phenoxyethanol, Iodopropynyl Butylcarbamate

Protocol: Shake well before use. Cleansing: Spray on the affected perineal area and remove with a moist washcloth. Aids in the removal of urine, feces and other foreign material. Ostomyl/Incontinence Appliance: To help control odor, spray into appliance before and after use.

NOVANA WASH PERINEAL SKIN CLEANSER 
benzethonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76077-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzethonium Chloride (Benzethonium) Benzethonium Chloride0.001 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sodium Laureth Sulfate 
POLYQUATERNIUM-7 (76/24 ACRYLAMIDE/DADMAC; 120 KD) 
Phenoxyethanol 
Iodopropynyl Butylcarbamate 
Packaging
#Item CodePackage Description
1NDC:76077-100-04120 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/04/2012
Labeler - NOVANA MEDICAL LLC (964916600)
Registrant - O.L. PRODUCTS, INC. (961405883)
Establishment
NameAddressID/FEIOperations
O.L. PRODUCTS, INC. 961405883label, manufacture

 
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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