Label: INDUSTRIAL STRENGTH WATERLESS HAND CLEANER- benzalkonium chloride lotion

  • NDC Code(s): 59555-302-03, 59555-302-04, 59555-302-08, 59555-302-09, view more
    59555-302-10, 59555-302-11
  • Packager: R & R Lotion, Inc
  • 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 January 15, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses

    A waterless hand cleaner that removes dirt and grime while killing germs, sanitizing, & remoisturizing your hands.

  • Warnings

    For external use only

    • When using this product, aviod contact with eyes
    • In case of eye contact, flush with water

    • Keep out of reach of children, except under adult supervision
    • If swallowed, get medical help
    • Discontinue use if skin irritation or redness develops
  • Directions

    Rub hand cleaner into dry hands until dirt or grease is dissolved & wipe dry with towel.

  • Ingredients

    Purified Water, Arlacel 165, Incroquat Behenyl TMS, Caprylic/Capric Triglyceride, Glycerin 99%, Shea Butter, Sunflower Butter, Floraesters K-20W, Lanette 16, Geogard Ultra, Xanthan Gum, Disodium EDTA, Pumice, Succulents (Jojoba, Blue Agave, Aloe Vera), Extracts (Acai, Aloe Whole Leaf, Blueberry, Cranberry, Grape Seed, Green Coffee, Green Tea, Pomegranate, Raspberry Fruit & Strawberry), Vitamin A & D, Vitamin E Acetate.

  • Questions or Comments?

    Call (480) 443-9255

  • PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label

    CRÈME

    STRENGTH
    INDUSTRIAL
    WATERLESS
    HAND CLEANER

    KILLS GERMS

    8 FL. OZ. (236ML) e

    PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    INDUSTRIAL STRENGTH WATERLESS HAND CLEANER 
    benzalkonium chloride lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-302
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Calcium Gluconate (UNII: SQE6VB453K)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    Behentrimonium Methosulfate (UNII: 5SHP745C61)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Glyceryl 1-Stearate (UNII: 258491E1RZ)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Shea Butter (UNII: K49155WL9Y)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    Glycerin (UNII: PDC6A3C0OX)  
    Potassium Hydrolyzed JOJOBA Esters (UNII: CH428W5O62)  
    cholecalciferol (UNII: 1C6V77QF41)  
    vitamin A (UNII: 81G40H8B0T)  
    Pumice (UNII: NT5NN5KL16)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59555-302-03 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2019
    2 NDC:59555-302-04 59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 05/01/2019
    3 NDC:59555-302-09 473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2019
    4 NDC:59555-302-08 236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 05/01/2019
    5 NDC:59555-302-10 946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2019
    6 NDC:59555-302-11 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part333A 05/01/2019
    Labeler - R & R Lotion, Inc (062979000)
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