Label: NOVACLENZ INSTANT HAND SANITIZER- alcohol soap

  • 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 February 7, 2018

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  • Active ingredient

    Ethyl Alcohol 62 % w/w

  • Purpose

    Antimicrobial

  • Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Uses

     to sanitize hands without requiring water or a rinse
     kills 99.9% of most common bacteria in 15 seconds

  • Warnings FLAMABLE For external use only

    When using this product

     do not use near heat or flame

     do not use in or near eyes

     discontinue use if irritation and redness develop
     do not use on deep or punture wounds, consult your doctor

  • Directions

     apply gel liberally to unsoiled hands and rub in thoroughly  allow to dry without wiping or rinsing

  • Other information

     store at room temperature

  • Inactive ingredients:

    Water, Carbomer, Diisopropylamine, Polysorbate 80 (and) Cetyl Acetate (and) Acetylated Lanolin Alcohol, Propylene Glycol (and) Diazolidinyl Urea (and) Methylparaben (and) Propylparaben

  • PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label NovaClenz™ Instant Hand Sanitizer with Emollients Micronova Manufacturing Inc. "Your Clean Room's worth it" Rapidly kills pathogenic micro-organisms on hands. Emollients Soften Dry Skin! Active Ingredient: 62% w/w Ethyl Alcohol Net contents: 2 Fl oz (59 ml)

    image description

  • INGREDIENTS AND APPEARANCE
    NOVACLENZ INSTANT HAND SANITIZER 
    alcohol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59764-522
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59764-522-1459 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/15/2013
    2NDC:59764-522-13500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/15/2013
    Labeler - Micronova (185829561)
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