Label: NOVANA WASH PERINEAL SKIN CLEANSER- benzethonium chloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated April 4, 2012

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  • ACTIVE INGREDIENT


    Active ingredient                                                                        Purpose
    Benzethonium Chloride 0.1 %......................................................Antiseptic

  • PURPOSE

    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

    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.

  • INDICATIONS & USAGE

    Directions Cleanse the affected area according to protocol.
  • INACTIVE INGREDIENT

    Inactive ingredients Water, Sodium Laureth Sulfate, Polyquaternium-7, Phenoxyethanol, Iodopropynyl Butylcarbamate
  • DOSAGE & ADMINISTRATION

    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.
  • PRINCIPAL DISPLAY PANEL

    Label of Product
  • INGREDIENTS AND APPEARANCE
    NOVANA WASH PERINEAL SKIN CLEANSER 
    benzethonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76077-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride0.001 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    POLYQUATERNIUM-7 (76/24 ACRYLAMIDE/DADMAC; 120 KD) (UNII: AAJ238UT03)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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/FEIBusiness Operations
    O.L. PRODUCTS, INC. 961405883label, manufacture
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