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 31, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 0.2%

  • Purpose

    Antiseptic

  • Use

    aids in the protection 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 20 mL (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
  • Other information

    • this rinse is not intended to replace brushing or flossing.
  • Inactive ingredients

    purified water, vegetable glycerin, polysorbate 80, flavor, erythritol, xylitol, poloxamer 407, citric acid, sodium benzoate, melaleuca alternifolia (tea tree) leaf oil.

  • 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.

    16 FL OZ (1 PT) 473 mL

    44956

    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)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    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 Product01/09/201901/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35601/09/201901/31/2025
    Labeler - Hello Products LLC (040714890)
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