FRESH PROTECT SKIN SANITIZER (BENZALKONIUM CHLORIDE) SPRAY [OMEGA TECH LABS INC.]

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FRESH PROTECT SKIN SANITIZER (BENZALKONIUM CHLORIDE) SPRAY [OMEGA TECH LABS INC.]
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NDC 20802-1502-1, 20802-1502-2
Set ID 4b570fd4-dd3f-499c-a01f-e47c0cb3f2e2
Category HUMAN OTC DRUG LABEL
Packager Omega Tech Labs Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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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 Spray
    Kills 99.99% of Germs
    No Alcohol
    8 fl. oz. (237 ml)

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

  • INGREDIENTS AND APPEARANCE
    FRESH PROTECT SKIN SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20802-1502
    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:20802-1502-189 mL in 1 BOTTLE, SPRAY
    2NDC:20802-1502-2237 mL in 1 BOTTLE, SPRAY
    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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