Label: ALCOHOL BASED HAND SANITIZER- ethyl alcohol solution

  • Category: HUMAN OTC DRUG LABEL

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 July 18, 2020

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  • Drug Facts

  • Active ingredient(s)

    Ethyl Alcohol 85% v/v

  • Purpose

    Antiseptic

  • Use(s)

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

    • on children less than 2 months of age

    • on open skin wounds

    When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
    • Denatured Alcohol, Ethyl Alcohol 85% as determined by hydrometer.
  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, hydrogen peroxide, purified water USP

  • SPL UNCLASSIFIED SECTION

    HIGHEST POTENCY 85% ETHANOL

    HAND SANITIZER FOR FASTER MORE COMPLETE SANITIZING OF HANDS AND OTHER SURFACES

    Highly effective while easy on your skin

    FDA APPROVED FORMULA

    non sterile solution

    MADE IN THE USA

    MANUFACTURED BY SKYBOUND SPIRITS
    IN SEATTLE WASHINGTON
    945 ELLIOT AVE WEST
    SEATTLE, WA 98119

    WWW.SEATTLESANITIZER.COM

  • Packaging

    IMAGEIMAGEIMAGEIMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    ALCOHOL BASED HAND SANITIZER 
    ethyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78539-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL85 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78539-001-0259.14 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:78539-001-04118.29 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:78539-001-08236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:78539-001-16473.17 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:78539-001-321890 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    6NDC:78539-001-643780 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Seattle Sanitizer LLC (130478322)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seattle Sanitizer LLC130478322manufacture(78539-001)
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