I.C. HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R&R LOTION, INC.]

I.C. HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R&R LOTION, INC.]
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NDC 59555-401-11, 59555-401-12, 59555-401-13
Set ID 5361bb71-cc84-4a76-a0cf-2259a615baa4
Category HUMAN OTC DRUG LABEL
Packager R&R Lotion, Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

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  • Purpose

    Antimicrobial

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  • Uses

    • For hand sanitizing to decrease bacteria on the skin
    • Recommended for repeated use
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  • Warnings

    For external use only

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • Pump a small amount of foam into palm of hand
    • Rub thoroughly over all surfaces of both hands
    • Rub hands together briskly until dry.
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  • Inactive Ingredients

    Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid

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  • Questions or Comments?

    Call (480) 443-9255
    or visit RRlotion.com

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  • PRINCIPAL DISPLAY PANEL - 591 ml Bottle Label

    R&R LOTION
    I.C. HAND SANITIZER™

    "ALCOHOL FREE"
    20 FL. OZ. (591ML) e

    Principal Display Panel - 591 ml Bottle Label
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  • INGREDIENTS AND APPEARANCE
    I.C. HAND SANITIZER 
    benzalkonium chloride aerosol, foam
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-401
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Cetrimonium Chloride (UNII: UC9PE95IBP)  
    Laurtrimonium Chloride (UNII: A81MSI0FIC)  
    Dihydroxyethyl Cocamine Oxide (UNII: 8AR51R3BL5)  
    Glycereth-17 Cocoate (UNII: 3057VPT0KC)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59555-401-12 591 mL in 1 BOTTLE, PUMP
    2 NDC:59555-401-11 3785 mL in 1 BOTTLE, PUMP
    3 NDC:59555-401-13 50 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part333A 06/15/2014
    Labeler - R&R Lotion, Inc. (062979000)
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