Label: CLEAN N FRESH INSTANT HAND SANITIZER- alcohol soap

  • 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 31, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 62% w/w

  • Purpose

    Antimicrobial

  • Uses

    • to sanitize hands without requiring water or a rinse
    • kills 99.9% of most common bacteria in 15 seconds
  • Warnings

    FLAMMABLE

    For external use only

    When using this product

    • do not use near heat or flame
    • do not use in or near eyes
    • discontinue use if irritation and redness develop
    • do not use on deep or puncture wounds, consult your doctor

    Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Directions

    • apply gel liberally to unsoiled hands and rub in thoroughly
    • allow to dry without wiping or rinsing
  • Other information

    • store at room temperature
  • Inactive ingredients

    Water, Aloe barbadensis leaf juice, Carbomer, Diisopropylamine, Glycerin, Isopropyl Myristate, Fragrance, Phenoxyethanol, Tocopheryl Acetate, D&C yellow #10, FD&C yellow #5, FD&C Blue #1

  • PRINCIPAL DISPLAY PANEL - 532 mL Pump Bottle Label

    Clean
    N
    Fresh     ®

    Instant
    hand
    sanitizer
    Antibacterial

    Net 18.0 Fl Oz (532 ml)

    Contains
    Moisturizers
    and
    Skin
    Conditioners

    with
    Aloe

    CARROLL®
    COMPANY

    Principal Display Panel - 532 mL Pump Bottle Label
  • INGREDIENTS AND APPEARANCE
    CLEAN N FRESH INSTANT HAND SANITIZER 
    alcohol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10685-520
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
    Product Characteristics
    Colorgreen (Clear green) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10685-520-17800 mL in 1 BAG; Type 0: Not a Combination Product10/01/2000
    2NDC:10685-520-25532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2000
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/01/2000
    Labeler - Carroll Company (007372329)
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