Label: CLEAN SKIN SANITIZER- hand sanitizer solution

  • NDC Code(s): 64542-300-35, 64542-300-46
  • Packager: State Industrial Products
  • 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 August 24, 2023

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  • DOSAGE & ADMINISTRATION

    Directions To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

  • INDICATIONS & USAGE

    Uses For hand cleaning to decrease bacteria on skin.

  • WARNINGS

    Warnings For exernal use only. FLAMMABLE. Keep away from heat or flame. Do not use in the eyes. In case of contact rinse thoroughly. Stp use and ask a doctor if irritation and redness appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out Of Reach Of Children. If swallowed, contact a physician or poison control center.

  • ACTIVE INGREDIENT

    Active Ingredient Ethyl Alcohol 62% v/v

  • PURPOSE

    Purpose Antibacterial Agent

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Acrylates/C10-30 Alkyl Acrylate Crossploymer, Propylene Glycol, Glycerine, Aloe Vera Gel, Fragrance, Triisopropanolamine, Blue 1, Yellow 5.

  • PRINCIPAL DISPLAY PANEL

    State Principal labelPrincipal Label

  • INGREDIENTS AND APPEARANCE
    CLEAN SKIN SANITIZER 
    hand sanitizer solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64542-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64542-300-46675 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2014
    2NDC:64542-300-35118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/14/2014
    Labeler - State Industrial Products (004520987)
    Registrant - Kutol Product Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(64542-300)
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