Label: NOURISHING HAND SANITIZING- benzalkonium chloride insert, extended release

  • NDC Code(s): 82289-1836-1
  • Packager: United States Mask LLC
  • 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 October 1, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

  • Purpose

    Benzalkonium chloride 0.13%.............................................Antiseptic

  • Uses

    Hand sanitizing and to decrease bacteria on the skin

  • Warnings

    • For external use only

    Do not use in the eyes.

    • In case of eye contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    • if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

    • Instruct children on proper use. If swallowed, get medical help, or contact a Poison Control Center right away.

  • Directions

    Apply small amount to hands and rub until dry. Lotion does not replace soap and water.

  • Other Information

    Store between 15-30°C (59-86°F). Avoid Freezing and excessive heat above 40°C (104°F)

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Starch, Behentrimonium Methosulfate, Caprylyl Glycol, Cetearyl Alcohol, Cetrimonium Chloride, Dimethicone, Glycerin, Hydrolyzed Soy Protein, Mentha Piperita (Peppermint) Essential Oil, Phenoxyethanol, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Vitamin A Palmitate, Vitamin E Acetate, Water.

  • PRINCIPAL DISPLAY PANEL

    Nourishing
    Hand
    Sanitizing
    Lotion

    100 ml/ 3.4 oz

    PRINCIPAL DISPLAY PANEL
Nourishing
Hand
Sanitizing
Lotion
100 ml/ 3.4 oz

  • INGREDIENTS AND APPEARANCE
    NOURISHING HAND SANITIZING 
    benzalkonium chloride insert, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82289-1836
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STARCH, OAT (UNII: 904CE6697V)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    JOJOBA OIL (UNII: 724GKU717M)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82289-1836-1100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/01/2021
    Labeler - United States Mask LLC (117771858)