Label: OOSAFE - benzalkonium chloride liquid

  • NDC Code(s): 52759-922-00, 52759-922-01, 52759-922-05, 52759-922-10
  • Packager: SPARMED ApS
  • 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 09/12

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  • Active Ingredient

        Benzlakonium Chloride 1.3 gram/liter.
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  • Purpose

    Disinfectant
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  • Warnings

    Harmful to health in case of in appropriate utilisation.Keep out of reach of children.

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  • Inactive Ingredients

    Water
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  • Keep Out of Reach of Children

    Keep out of reach of children

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  • Dosage and Administration

    Apply evenly on the surface wait 15 minutes to dry out for the best results and clean with sterile sponge or cloth impregnated sterile water.

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  • Indication and Usage

    Disinfectant -effective against hepatitis B HIV Rota virus with in 1 minute, mycobacterium with in 5 minute, and bacteria fungi (candida), influenza A virus (H5N1/H1N1) with in 15 minutes.

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  • Package Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    OOSAFE 
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52759-922
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52759-922-01 1 L in 1 BOTTLE
    2 NDC:52759-922-05 5 L in 1 BOTTLE
    3 NDC:52759-922-10 10 L in 1 BOTTLE
    4 NDC:52759-922-00 0.250 L in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 04/30/2012
    Labeler - SPARMED ApS (311811306)
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