Label: VYDAL SCENTED HAND SANITIZER 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 June 15, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient [s] Purpose

    Alcohol 80% v/v.......................................Antiseptic

  • DO NOT USE

    Do not use

    • In children under 2 months of age.
    • On open skin wounds.

  • 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.

  • ASK DOCTOR

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • WARNINGS

    Warnings

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

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. NOT FOR CONSUMPTION. DO NOT INGEST.

  • OTHER SAFETY INFORMATION

    Other Information

    • Store between 15°-30°C (59°-86°F)
    • Avoid freezing and excessive heat above 40°C (104°)
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Gylcerin, Hydrogen Peroxide, Orange Oil, Eucalyptus Oil, English Lavender Oil, Purified Water USP

  • DOSAGE & ADMINISTRATION

    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.
  • INDICATIONS & USAGE

    Use [s]

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

    Use [s]

    • Hand sanitizer helps reduce bacteria that potentially causes disease.
    • For use when soap and water are not available.
  • PRINCIPAL DISPLAY PANEL

    VYDAL 100 ml labelVYDAL

    80% Alcohol

    Scented Hand Sanitizer

    Cleansing Zen

    • WHO Rocommended Hand Rub

    Formulation #1

    • FOR EXTERNAL USE ONLY
    • NOT SAFE FOR CONSUMPTION
    • NON-STERILE SOLUTION

    3.4 fl oz/100 mL

    MADE IN USA

  • INGREDIENTS AND APPEARANCE
    VYDAL SCENTED HAND SANITIZER 
    vydal scented hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74563-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL800 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WATER (UNII: 059QF0KO0R) 184.2 mL  in 1000 mL
    GLYCEROL FORMAL (UNII: 3L7GR2604E) 14.5 mL  in 1000 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 1.3 mL  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74563-003-01100 mL in 1 BOTTLE, PLASTIC; 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 - List Distillery, LLC (087028906)
    Registrant - List Distillery, LLC (087028906)
    Establishment
    NameAddressID/FEIBusiness Operations
    List Distillery, LLC087028906manufacture(74563-003)
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