Label: CRISP APPLE HAND SANI- 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 March 11, 2016

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  • Active ingredient

    Ethyl Alcohol 65%

  • 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 heat and flame

  • When using this product

    • keep out of eyes. Incase of contact with eyes, flush thoroughly with water.
    • do not inhale or ingest
    • avoid contact with broken skin
  • 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 hands thoroughly with product and allow to dry without wiping
    • for children under 6, use only under adult supervision
    • not recommed for infants
  • Other Information

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

    benzophenone-4, carbomer, cellulose, fragrance, glycerin, hydroxypropyl methylcellulose, mannitol, red 4, red 40, retinyl palmitate, tocoperyl acetate, ultamarines, water

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

    Questions 1-888-593-0593

    *Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds

  • Principal Display Panel

    Meijer

    Hand Sanitizer

    Crisp Apple

    Kills 99.99% of germs*

    2 FL OZ (59 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CRISP APPLE HAND SANI 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-607
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL585 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SULISOBENZONE (UNII: 1W6L629B4K)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MANNITOL (UNII: 3OWL53L36A)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-607-1659 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/11/2016
    Labeler - Meijer Distribution, Inc (006959555)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon150931459manufacture(41250-607)
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