Label: I.C. ANTIBACTERIAL HAND CLEANER- benzalkonium chloride soap

  • NDC Code(s): 59555-701-08, 59555-701-09, 59555-701-10, 59555-701-11
  • 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 September 24, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Uses

    For handwashing to decrease bacteria on the skin

  • Warnings

    For external use only

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

    Stop use and ask a doctor if irritation or redness develops.

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

  • Directions

    • Pump into DRY hands.
    • Lather vigorously for at least 15 seconds
    • Rinse and dry throughly
  • Inactive Ingredients

    Water, Triethanolamine Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide Monoethanolamine, Sodium Chloride, Gluconolactone (and) Sodium Benzoate, Citric Acid, Sodium Hydroxide

  • PRINCIPAL DISPLAY PANEL - 946 ml Bottle Label

    I.C.®
    Antibacterial
    Hand
    Cleaner

    R&R LOTION
    USA

    Kills Germs

    32oz. (946ml) ℮

    Principal Display Panel - 946 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    I.C. ANTIBACTERIAL HAND CLEANER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-701
    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)  
    Triethanolamine Lauryl Sulfate (UNII: E8458C1KAA)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-701-08236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2021
    2NDC:59555-701-09473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2021
    3NDC:59555-701-10946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2021
    4NDC:59555-701-113780 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A07/01/2021
    Labeler - R & R Lotion, Inc (062979000)
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