Label: CLEAN N NATURAL HAND SANITIZER ANTIMICROBIAL- alcohol gel

  • NDC Code(s): 67385-025-01, 67385-025-02, 67385-025-03, 67385-025-04, view more
    67385-025-13
  • Packager: Garcoa, Inc.
  • 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 27, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Uses

    ⬥
    Hand sanitizer to help reduce bacteria on the skin that could cause disease
    ⬥
    Recommended for repeated use
  • Warnings

    Flammable. Keep away from fire or flame.

    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..

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    ⬥
    place enough product in your palm to thoroughly cover your hands
    ⬥
    Rub hands together briskly until dry.
    ⬥
    Children under 6 years of age should be supervised when using this product.
  • Other information

    ⬥
    Store at room temperature
    ⬥
    May discolor certain fabrics or surfaces.
  • Inactive ingredients

    AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Citrus Limon (Lemon) Peel Oil, Fragrance, Glycerin, Isopropyl Myristate, PEG-6, Propylene Glycol, Tocopheryl Acetate, Water

  • Questions or comments?

    1-866-567-8600

  • PRINCIPAL DISPLAY PANEL - 3 Bottle Carton

    3 PACK
    (FULL SIZE 12 FL OZ)

    clean n' natural®

    HAND
    SANITIZER

    ALCOHOL
    70%
    BASED

    Helps reduce pathogenic
    germs on hands

    With moisturizers and vitamin E

    Contains: 3 Pump Closure 12 FL. OZ. / 354 mL Bottles • Total: 36 FL. OZ. / 1062 mL

    PRINCIPAL DISPLAY PANEL - 3 Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CLEAN N NATURAL HAND SANITIZER   ANTIMICROBIAL
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67385-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67385-025-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2020
    2NDC:67385-025-02236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2020
    3NDC:67385-025-133 in 1 CARTON06/30/2020
    3NDC:67385-025-03354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:67385-025-043785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E06/30/2020
    Labeler - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan America, LLC964976968MANUFACTURE(67385-025)
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