Label: PURELOGIC ANTIBACTERIAL WIPES SAGE LAVENDER 2 TRAVEL PACKS- benzalkonium 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 July 25, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.2%

  • PURPOSE

    Purpose: 

    Disinfectant

  • USE

    Decrease bacteria on skin that could cause disease

    Recommended for repeated use

  • warnings

    For external use only on hands. Flammable, keep way from flame or fire

  • When using this product

    When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water

    Do not ingest or inhale

    Avoid contact with broken skin

  • stop use and ask a doctor

    if irrigation and redness develop and condition persists for more than 72 hours

  • keep out of reach of children

    if swallowed,get medical help or contact a Poison Control Center immediately

  • Directions

    • Wipe product on hands thoroughly and allow to dry, do not wipe off
    • For children under 6, use under adult supervision
    • Not recommended for use with infants
  • other information

    Do not store above 105F (40.6C)

    May discolor some fabrics

    Harmful to plastics and wood finishes

  • inactive ingredients

    Purified water, Phenoxyethanol, Ethylhexylglycerin, Didecyldimonium Chloride, Propylene  Glycol, Glycerin, Fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PURELOGIC ANTIBACTERIAL WIPES SAGE LAVENDER 2 TRAVEL PACKS 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77731-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.006 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77731-020-012 in 1 PACKAGE07/24/2020
    130 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/24/2020
    Labeler - Argento sc by sicura inc. (168718778)
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