Label: HAND SANITIZER- ethyl alcohol liquid

  • NDC Code(s): 78684-080-01
  • Packager: STILL VALLEY SPIRITS LLC
  • 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 ingredient(s)

    Denatured Ethyl Alcohol 80% v/v 

  • Purpose(s)

    Antiseptic

  • Uses(s)

    Hand sanitizer to help reduce bacteria that can potentially cause disease. For use when soap or 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

    • Spray 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 15-30°C (59-86°F)

    • Avoid freezing and excessive heat above 40°C (104°F)

  • Inactive ingredient(s)

    • Distilled or Boiled Water, Hydrogen Peroxide, Glycerin

  • SPL UNCLASSIFIED SECTION

    Formula Based on FDA Compounding Guidlines for consumer and healthcare personnel use, issued March 2020.

    Best used for refilling spray bottles.

    Not for human consumption. External use only.

    Produced by Still Valley Spirits LLC Puyallup, WA

    Contents may separate naturally. Shake well.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78684-080
    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)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78684-080-01750 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/15/2020
    Labeler - STILL VALLEY SPIRITS LLC (122659099)
    Establishment
    NameAddressID/FEIBusiness Operations
    STILL VALLEY SPIRITS LLC122659099manufacture(78684-080)
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