Label: NEPTUNE E2 ANTISEPTIC FOAM HAND- benzalkonium chloride soap

  • NDC Code(s): 61159-000-00
  • Packager: R. L. Williams Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

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  • Soap Pro Neptune E2 ANTISEPTIC FOAM HAND SOAP
  • Active ingredient

    Benzalkonium Chloride 0.13%

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  • Purpose

    Antimicrobial

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  • Uses

    • Handwash to help decrease bacteria on the skin
    • Recommended for repeated use
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  • Warnings

    For external use only

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts more than 72 hours.

    Keep out or 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 for 15 seconds
    • Rinse with potable water
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  • Inactive ingredients

    Water, coco-glucoside, laurtrimonium chloride, cocamidopropylamine oxide, citric acid

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  • Soap Pro Neptune E2 ANTISEPTIC FOAM HAND SOAP 30.4oz/900ml
  • INGREDIENTS AND APPEARANCE
    NEPTUNE E2 ANTISEPTIC FOAM HAND 
    benzalkonium chloride soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61159-000
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    COCO GLUCOSIDE  
    LAURTRIMONIUM CHLORIDE  
    COCAMIDOPROPYLAMINE OXIDE  
    CITRIC ACID MONOHYDRATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61159-000-00 900 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 11/14/2013
    Labeler - R. L. Williams Company (099976362)
    Establishment
    Name Address ID/FEI Business Operations
    Formula Corp. 040509648 manufacture(61159-000)
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