Label: GREEN APPLE HAND SANITIZER- alcohol gel

  • NDC Code(s): 55165-0203-1, 55165-0203-2
  • Packager: Juice Beauty
  • 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 January 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70% (derived from non GMO corn)

  • Purpose

    Antiseptic

  • Uses

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap & water are not available.

  • 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.

    Stop use and ask doctor - if skin irritation develops.

    Keep out of reach of children. If product is 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 recommended for infants.

  • Other Information

    • Store between 15-30C (59-86F)
    • Avoid freezing & excessive heat above 40C (104F)
  • Inactive Ingredients

    Acetyl Octapeptide-3, Caprylyl Glycol, Cinnamomum Camphora Oil1, Citrus Aurantium dulcis (Orange) Oil1, Glycerin (plant derived)1, Hydroxypropyl Cellulose, Litsea Cubeba Fruit Oil1, Silica (mineral), Water.

    1
    plant derived
  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    juice BEAUTY

    GREEN APPLE®
    Hand Sanitizer

    Kills 99.9% of most germs
    70% alcohol
    (derived from non-GMO corn)
    Peptides & Vegetable Glycerin

    237 mL / 8 fl oz

    PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    GREEN APPLE HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55165-0203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    acetyl octapeptide-3 (UNII: 8K14HJF88S)  
    Caprylyl glycol (UNII: 00YIU5438U)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    Glycerin (UNII: PDC6A3C0OX)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    LITSEA OIL (UNII: 2XIW34BN6O)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55165-0203-1237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/22/2020
    2NDC:55165-0203-259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A05/22/2020
    Labeler - Juice Beauty (263151582)
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