Label: HAND SANITIZER- alcohol gel

  • 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 March 3, 2022

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  • Active ingredient

    Ethyl alcohol 70%

  • 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. 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

    • skin irritation 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 witout wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Other information

    • do not store above 105⁰ F
    • may discolor some fabrics
    • harmful to wood finishes and plastics
  • Inactive ingredients

    water, aloe barbadensis leaf juice,glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4, blue 1, yellow 5

  • Questions?

    1-888-593-0593

  • SPL UNCLASSIFIED SECTION

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

    Distributed by CDMA, Inc.

    43157 W Nine Mile

    Novi, MI 48376

    www.qualitychoice.com

    Questions 800-935-2362

  • principal display panel

    QC QUALITY CHOICE

    Compare to Germ-X Advanced Hand Sanitizer with Aloe

    Advanced

    Hand Sanitizer

    With Aloe

    Kills More Than 99.99% of Germs*

    Leaves hands feeling soft

    With Moisturizer & Vitamin E

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-439
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.70 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-439-34236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/05/2021
    Labeler - CDMA (011920774)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(63868-439)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(63868-439)
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