Label: HELLO HAND SANITIZER - FRESH MINT AND TEA TREE OIL- alcohol spray

  • 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 November 30, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient(s)

    Ethyl alcohol 62%

  • Purpose

    Antiseptic

  • Use(s)

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

  • Warnings

    For external use only. Do not spray toward face.

    Flammable. Keep away from heat or flame.

    Do not use in children less than 2 months of age or on open skin wounds.

    When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • Directions

    • Spray enough product on hands to cover all surfaces
    • Rub hands together until dry
    • Supervise children under 6 years of age.
  • Other information

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

    Water, Triethyl Citrate, Sodium L-pyroglutamate, Fragrance, Mixed Tocopherols

  • SPL UNCLASSIFIED SECTION

    Dist. by Hello Products LLC
    Montclair, NJ 07042

  • PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

    naturally
    friendly
    hello®

    antibacterial
    hand sanitizer spray

    never tested
    on animals

    with natural
    fragrance

    fresh mint + tea tree oil

    2 FL OZ/59mL

    PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HELLO HAND SANITIZER - FRESH MINT AND TEA TREE OIL 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PIDOLATE (UNII: 1V74VH163T)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55882-6109-159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2020
    Labeler - Hello Products LLC (040714890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Myku Biosciences106728135MANUFACTURE(55882-6109)