Label: I.C. SANITIZER AND RE-MOISTURIZER WITH BENZALKONIUM CHLORIDE- benzalkonium chloride lotion

  • NDC Code(s): 59555-903-03, 59555-903-04, 59555-903-06, 59555-903-08, view more
    59555-903-09, 59555-903-10, 59555-903-11, 59555-903-16
  • 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 9, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses

    Hand Sanitizer to decrease bacteria on the skin. Recommended for repeated use.

  • Warnings

    For external use only

    • When using this product, avoid 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
    • Do not use on broken skin
  • Directions

    Rub onto hands until absorbed.

  • Ingredients

    Purified Water, Cetearyl Alcohol (and) Behentrimonium Methosulfate, Glyceryl Stearate (and) PEG-100 Stearate, C/C Triglyceride, Sunflower Butter, Glycerin, Dimethicone, Cetyl Alcohol, Hydrolyzed Jojoba Esters, Gluconolactone (and) Sodium Benzoate, Shea Butter, Xanthan Gum, Disodium EDTA, Propylene Glycol, Vaccinium Macrocarpon (Cranberry) Fruit, Coffea Robusta Seed, Fragaria Vesca (Strawberry) Fruit, Euterpe Oleracea Fruit, Vaccinium Angustifolium (Blueberry) Fruit, Camellia Sinensis (Green Tea) Leaf, Vitis Vinifera (Grape) Seed, Punica (Pomegranate) Granatum Fruit, Rubus Idaeus (Raspberry) Fruit, Potassium Sorbate, Agave Tequilana Leaf (Blue Agave), Simmondsia Chinensis (Jojoba) Seed, Aloe Barbadensis Leaf Juice (Aloe Vera), Vitamin E Acetate, Vitamin A (and) D

  • Samples & Comments?

    Call (480) 443-9255
    visit RRlotion.com

  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    I.C.®
    Hand
    Sanitizing
    Cream

    R&R LOTION
    USA

    Kills Germs

    8oz (236ml) ℮

    PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    I.C. SANITIZER AND RE-MOISTURIZER WITH BENZALKONIUM CHLORIDE 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-903
    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)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    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)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-903-0350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/02/2018
    2NDC:59555-903-0459 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2018
    3NDC:59555-903-09473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/02/2018
    4NDC:59555-903-08236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2018
    5NDC:59555-903-10946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/02/2018
    6NDC:59555-903-113785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/02/2018
    7NDC:59555-903-06100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/02/2018
    8NDC:59555-903-164 mL in 1 PACKET; Type 0: Not a Combination Product05/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A12/21/2015
    Labeler - R & R Lotion, Inc (062979000)
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