Label: 4K HANDFULL- ethyl alcohol gel

  • 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 June 23, 2020

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  • Drug Facts

  • Active Ingredients

    Ethyl Alcohol 80% v/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use Repeatedly as a hand sanitizer to help reduce bacteria on skin. Wash hands first when possible.

  • Warnings

    Flammable. Keep away from heat or flame.

    For external use only

    Keep from eyes. If contact occurs, rinse with water.

    See A Doctor if rash or redness appears.

    Keep Out Of Reach Of Children.

    If swallowed, get medical help or contact a Poison Control Centre immediately.

  • DOSAGE & ADMINISTRATION

    Directions: Apply gel liberally to cover hands. Rub hands together vigorously until dry.

    Supervise children of 6 years and under when using.

  • Other Information

    • Store below 105°F (40°C)

    • May discolor certain fabrics or surfaces

  • Inactive Ingredients

    Purified Water USP, Glycerin, Klucel (TM) Hydroxypropyl, Tocopherol Acetate (Vitamin E) Oil, Lavandula Augustiflora (Lavender) Essential Oil, Rosemarinus Officinalis (Rosemary) Essential Oil

  • SPL UNCLASSIFIED SECTION

    SIAN RICHARDS

    LONDON

    WITH

    VITAMIN E  

    ENGLISH LAVENDER and ROSEMARY ESSENTIAL OILS

    RUB IT IN & FEEL BETTER

    FOR BIRDS AND BLOKES

    Manufactured in USA for 

    London Brush Company Inc

    EI Segundo, CA 90245

    SIANRICHARDSLONDON.COM

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    4K HANDFULL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74836-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74836-101-11100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/23/2020
    Labeler - London Brush Company (068140049)
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