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 May 22, 2019

If you are a consumer or patient please visit this version.

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-302-0350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2019
    2NDC:59555-302-0459 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/01/2019
    3NDC:59555-302-09473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2019
    4NDC:59555-302-08236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product05/01/2019
    5NDC:59555-302-10946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2019
    6NDC:59555-302-113785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A05/01/2019
    Labeler - R & R Lotion, Inc (062979000)