Label: INDUSTRIAL SANITIZING- benzethonium chloride and dimethicone lotion

  • 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 December 8, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Benzethonium Chloride 0.2%Antibacterial
    Dimethicone 2.0%Skin Protectant
  • Uses

    Skin protectant, temporarily protects against harmful Pathogens & Stimuli while killing 99.99% of Germs for up to Four Hours.

  • 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 into hands and body until absorbed.

  • Ingredients

    DI Water, Incroquat TMS, Propylene Glycol, Sunflower Butter, Octyl Palmitate, Stearyl Alcohol, Cetyl Alcohol, Geoguard Ultra, Aloe Vera, Jojoba, Blue Agave, Blueberry, Cranberry, Pomegranate, Raspberry, Strawberry, Green Tea, Green Coffee Bean, Grape Seed, Acai Berry, Vitamins A, D, & E

  • Questions or Comments?

    Call (480) 443-9255

  • PRINCIPAL DISPLAY PANEL - 118 ML Bottle Label

    HAND LOTION

    STRENGTH

    INDUSTRIAL
    HAND SANITIZER

    FOUR HOUR
    PROTECTION

    4 FL. OZ. (118ML) e

    PRINCIPAL DISPLAY PANEL - 118 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    INDUSTRIAL SANITIZING 
    benzethonium chloride and dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride2 mg  in 1 mL
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    cholecalciferol (UNII: 1C6V77QF41)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    vitamin A (UNII: 81G40H8B0T)  
    Behentrimonium Methosulfate (UNII: 5SHP745C61)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Calcium Gluconate (UNII: SQE6VB453K)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-902-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:59555-902-0459 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:59555-902-10946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:59555-902-113785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    5NDC:59555-902-1350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    6NDC:59555-902-07118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A12/21/2015
    Labeler - R&R Lotion, Inc. (062979000)