Label: WINTER APPLE- hand sanitizer 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 December 12, 2022

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  • Active ingredient

    Ethyl alcohol 62%

  • Purpose

    Antiseptic  

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only: hands

    Flammable.  Keep away from fire or flame

  • When using this product

    • keep out of eyes.  In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin
    • do not inhale or ingest
  • Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more than 72 hours
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet hand thoroughly with product and allow to dry without wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Other information

    • do not store above 105°F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    water, glycerin, carbomer, fragrance, red 40, red 33

  • SPL UNCLASSIFIED SECTION

    EFFECTIVE AT ELIMINATING 99.99% OF MANY COMMON HARMFUL GERMS AND BACTERIA IN AS LITTLE AS 15 SECONDS*

    DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

    QUALITY GUARANTEE

    800-632-6900  www.kroger.com

  • Principal Panel Display

    Kroger

    WINTER APPLE

    Kills 99.99% of Germs

    HAND SANITIZER

    2 FL OZ (59 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    WINTER APPLE 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-803
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-803-1659 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/24/2016
    Labeler - Kroger, CO., (006999528)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(30142-803)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(30142-803)