Label: GRAYDON NATURAL-HYDRATING- ethyl alcohol liquid

  • 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 December 6, 2021

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient: Ethyl alcohol 72% v/v

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    Uses: Kills harmful bacteria and germs. For personal
    hand hygiene to help prevent the spread of bacteria.
    For use when soap and water are not available.

  • WARNINGS

    Warnings: For external use only.
    Flammability. Keep away from open flame and
    sources of heat.

  • DO NOT USE

    Do not use: on children less than 2 years old or on
    open skin wounds.

  • WHEN USING

    When using this product keep out of eyes, ears and
    mouth. In case of contact with eyes, rinse eyes
    thoroughly with water.

  • STOP USE

    Stop use and consult a health care practitioner if
    irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get
    medical help or contact a Poison Control Center right
    away.

  • DOSAGE & ADMINISTRATION

    Directions: Place enough product on hands to cover
    all surfaces. Rub hands together until dry.
    Supervise children when they use this product to avoid
    swallowing.

  • OTHER SAFETY INFORMATION

    OTHER INFORNMATION
    ·Store between 15-30C (59-86F)
    ·Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Inactive ingredients: sea silt extract*,
    glycerin, aloe barbadensis leaf juice,
    aqua, vaccinium angustifolium (blueberry)
    fruit extract, calendula officinalis
    flower extract, lavandula angustifolia
    (lavender) essential oil, litsea cubeba
    fruit oil, polyacrylate crosspolymer-6
    *glacial oceanic mineral water

  • Package Labeling

    n o u r i s h i n g

    HAND

    SANITIZER

    72% alcohol


    k i l l s  h a r m f u l  g e r m s
    a n d  b a c t e r i a

    GRAYDON

    N a t u r a l - H y d r a t i n g

    2  fl  oz  /  60  mL

    7 4 9 8 3 - 4 6 3 - 0 1

    Manufactured by: Ironwood Clay
    Company Inc. Richmond, BC V6V2L9
    Canada

    Distributed by: Graydon Skincare.
    Toronto, ON M4K1A7 Canada.
    graydonskincare.com
    Made in Canada

    463-01 4OZ

    res

  • INGREDIENTS AND APPEARANCE
    GRAYDON NATURAL-HYDRATING 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79483-463
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    VACCINIUM ANGUSTIFOLIUM LEAF (UNII: B4L873GNG1)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LITSEA CUBEBA FRUIT (UNII: R3617MQA5Z)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79483-463-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2020
    Labeler - Graydon Skincare (203821500)
    Registrant - Graydon Skincare (203821500)
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