Label: SIT CLEAN- benzalkonium chloride cloth

  • 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 August 18, 2016

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  • Uses

    • For hand sanitizing to decrease bacteria on the skin when water and soap are not available.
    • Recommended for repeated use
  • Active Ingredient

    Benzalkonium Chloride .13%

  • Purpose

    Antimicrobial

  • Warnings

    • ​For external use only
    • When using this product do not use in or near eyes. If contact occurs, flush thoroughly with water.
  • Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Inactive ingredeints

    Aloe Barbadensis Leaf Juice, Citric Acid, Fragrance, Glycerin, Hamamelis, Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Polysorbate 20,Tocopheryl Acetate, Water

  • Dosage and Administration

    • Peel back label
    • Remove and unfold wipe
    • Wipe hands thoroughly for approximately 30 seconds
    • Dispose of used wipe in trash, do not flush
    • Reseal pouch after each use
  • SPL UNCLASSIFIED SECTION

    Designed, Formulated and assembled in the USA

    Sit Clean TM

    N. Ft. Myers, FL 33918

    www.sitclean.net

  • Principal display panel

    Sit Clean

    Don't hover wipe that cover TM

    Alcohol-free

    Sanitary wipes

    Easy to use

    Toilet Seat Wipes

    Antibacterial hand wipes

    Helps kill germs on hands when used as a hand wipe

    Label and film

  • INGREDIENTS AND APPEARANCE
    SIT CLEAN 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70881-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.13 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorwhiteScore    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70881-100-2012 g in 1 POUCH; Type 0: Not a Combination Product08/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/23/2016
    Labeler - Sit Clean (006237086)
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