Label: FRESH PROTECT SKIN SANITIZER- benzalkonium chloride lotion

  • 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 0.13%

  • 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, Emulsifying Wax NF, Behentrimonium Methosulfate, Centrimonium Chloride, Dimethicone, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate E, Retinyl Palmitate A, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Hydrolyzed Soy Protein, Butylene Glycol, Avena Sativa (Oat) Extract, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Tetrasodium EDTA, Peppermint Essential Oil.

  • PRINCIPAL DISPLAY PANEL

    Fresh Protect
    96.9% Natural
    Skin Sanitizer Product
    Kills 99.99% of Germs
    No Alcohol
    8 fl. oz. (237 ml)

    PRINCIPAL DISPLAY PANEL Fresh Protect Skin Sanitizer Product 8 fl. oz. (237 ml)

  • INGREDIENTS AND APPEARANCE
    FRESH PROTECT SKIN SANITIZER 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20802-1500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.0013 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    AVENA SATIVA LEAF (UNII: 206PI19V7R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20802-1500-114 mL in 1 BOTTLE
    2NDC:20802-1500-289 mL in 1 BOTTLE
    3NDC:20802-1500-3237 mL in 1 BOTTLE, PUMP
    4NDC:20802-1500-4473 mL in 1 BOTTLE, PUMP
    5NDC:20802-1500-5800 mL in 1 BAG
    6NDC:20802-1500-63785 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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