Label: RUGID OUTDOORS HAND SANITIZER BENZALKONIUM CHLORIDE- benzalkonium chloride lotion

  • NDC Code(s): 59555-910-07, 59555-910-18
  • 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 14, 2021

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses

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

  • 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 onto hands until absorbed.

  • 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, 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 or visit RugidProducts.com

  • PRINCIPAL DISPLAY PANEL - 118 ML Bottle Label

    RUGID
    OUTDOORS
    EST. 84

    ALCOHOL FREE
    HAND SANITIZER

    HAND CREAM

    FRAGRANCE FREE

    PARABEN FREE

    NON-FLAMMABLE

    USA

    4 FL. OZ. (118ML) e

    PRINCIPAL DISPLAY PANEL - 118 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    RUGID OUTDOORS HAND SANITIZER BENZALKONIUM CHLORIDE 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-910
    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)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-910-181 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2019
    2NDC:59555-910-07118 mL in 1 BOTTLE, DISPENSING; 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!