Label: HELLO NATURALLY FRESH ANTISEPTIC- menthol, unspecified form mouthwash

  • 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 26, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 0.2%

  • Purpose

    Antiseptic

  • Use

    First aid to help protect against oral infection.

  • Warnings

    Ask a dentist if symptoms persist or condition worsens after regular use.

    Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and older: Rinse for 30 seconds with 20mL (about 1 capful) twice a day. Do not swallow.
    • children 6 years to under 12 years of age: supervise use.
    • children under 6 years of age: do not use
  • Inactive ingredients

    purified water, vegetable glycerin, polysorbate 80, flavor, xylitol, erythritol, poloxamer 407, sodium benzoate and tea tree oil.

  • Other Information

    this rinse is not intended to replace brushing or flossing.

  • Questions?

    1-855-444-3556

  • SPL UNCLASSIFIED SECTION

    Dist. by Hello Products LLC
    Montclair, NJ 07042

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    naturally
    friendly
    hello®

    naturally fresh™
    antiseptic mouthwash

    natural fresh mint
    with farm grown peppermint

    kills germs
    freshens breath
    rocks tastebuds
    no alcohol

    never tested
    on animals

    16 FL OZ (473mL)

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HELLO   NATURALLY FRESH ANTISEPTIC
    menthol, unspecified form mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55882-6102
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Xylitol (UNII: VCQ006KQ1E)  
    Erythritol (UNII: RA96B954X6)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Tea tree oil (UNII: VIF565UC2G)  
    Sodium benzoate (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55882-6102-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35601/09/2019
    Labeler - Hello Products LLC (040714890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac071609663MANUFACTURE(55882-6102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutrix117341868MANUFACTURE(55882-6102)