Label: FRESH PROTECT SKIN SANITIZER- benzalkonium chloride liquid

  • 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 January 2, 2011

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Benzalkonium chloride 0.1%

  • Purpose

    Antiseptic

  • Uses

    For hand sanitizing. To decrease bacteria on the skin.

  • Warnings

    For external use only.

    Do not use

    in the eyes. In case of eye contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or redness develops, or if condition persists more than 72 hours.

    Keep out of reach of children.

    Instruct children on proper use. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply a small amount on your hands. Rub hands together until dry. When hands are visibly soiled, wash with soap and water.

  • Inactive Ingredients

    Water, Aloe Barbadensis Leaf Extract, Glycerin, Citrus Grandis (Grapefruit) Seed Extract, Thymus Vulgaris (Thyme) Extract, Camellia Sinensis Leaf (Green Tea) Extract, Avena Sativa (Oat) Extract, Peppermint Essential Oil, Polysorbate 20, Potassium Sorbate, Sodium Benzoate.

  • PRINCIPAL DISPLAY PANEL

    Fresh Protect
    99.9% Natural
    Skin Sanitizer Foam
    Kills 99.99% of Germs
    No Alcohol
    7.5 fl. oz. (222 ml)

    PRINCIPAL DISPLAY PANEL Fresh Protect Skin Sanitizer Foam 7.5 fl. oz. (222 ml)

  • INGREDIENTS AND APPEARANCE
    FRESH PROTECT SKIN SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20802-1501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PUMMELO (UNII: ET1TN5W71X)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    AVENA SATIVA LEAF (UNII: 206PI19V7R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20802-1501-150 mL in 1 BOTTLE
    2NDC:20802-1501-2222 mL in 1 BOTTLE
    3NDC:20802-1501-3800 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A12/16/2010
    FRESH PROTECT SKIN SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20802-1503
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PUMMELO (UNII: ET1TN5W71X)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    AVENA SATIVA LEAF (UNII: 206PI19V7R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20802-1503-13785 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A12/16/2010
    Labeler - Omega Tech Labs Inc. (019313817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Omega Tech Labs Inc019313817MANUFACTURE
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