Label: CLEAN N NATURAL HAND SANITIZER ANTIMICROBIAL- alcohol gel

  • NDC Code(s): 67385-024-01, 67385-024-02
  • 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 20, 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 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

    Aminomethyl Propanol, Carbomer, Glycerin, Tocopheryl Acetate, Water.

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Clean n' Natural® Products
    Calabasas, CA 91302

  • PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

    clean n' natural®

    HAND
    SANITIZER

    ALCOHOL
    70%
    BASED

    ALCOHOL BASED
    FORMULA

    Helps reduce pathogenic
    germs on hands

    With moisturizers
    and vitamin E

    Works without water

    2 fl. oz. (59 mL)

    PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CLEAN N NATURAL HAND SANITIZER   ANTIMICROBIAL
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67385-024
    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
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .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:67385-024-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/20/2020
    2NDC:67385-024-02236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E04/20/2020
    Labeler - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(67385-024)
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