Label: YOOLOGY ALCOHOL-FREE HAND SANITIZER- benzalkonium chloride cream

  • 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 13, 2021

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  • Active ingredient

    Benzalkonium chloride 0.066w/w%

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing. Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.) This product is intended only for hand sanitizing. To prevent contents from drying out and contaminants from entering, close lid completely after use. Do not use over bandages, castings, etc. as irritation may occur.

  • Warnings

    For exteral use only.

  • Stop use and ask a doctor

    if irritation or rash occurs. These may be signs of a serious conditon.

  • Do not use

    • In children less than 2 months of age
    • On open skin wounds
  • Keep out of reach of children

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

  • When using this product

    keep out of eyes, ears and mouth. In case of contract with eyes, rinse eyes thoroughly with water.

  • Use

    Disinfection of hands

  • Other information

    Store between 15~30ºC(59~86ºF) Avoid freezing and excessive heat above 40ºC (104ºF)

  • Inactive Ingredients

    Water, Glycerin, Mineral Oil, Cetearyl Alcohol, GlycerylStearate, Sorbitan Stearate, Polysorbate 60, Microcrystalline Wax, Phenoxyethanol, Chlorphenesin,Dimeticone, Carbomer, Trietanolamine, Caprylic/Capric Triglyceride, Disodium EDTA, Allantoin,Sodium Hyaluronate, Lavendula Angustifolia (Lavender)Extract, Portulaca Oleracea Extract, PEG-100 Stearate, Fragrance

  • Purpose

    Antiseptic

  • PRINCIPAL DISPLAY PANEL

    300 mL

  • INGREDIENTS AND APPEARANCE
    YOOLOGY ALCOHOL-FREE HAND SANITIZER 
    benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73823-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.198 g  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PURSLANE (UNII: M6S840WXG5)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73823-301-01300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/13/2021
    Labeler - WHAIN COSMETIC (557837595)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHAIN COSMETIC695520590manufacture(73823-301)