Hello

Manufacturer
Hello Products LLC
Effective date
2023-03-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:33:32

Label at a glance#

ProductHello naturally fresh antiseptic
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Dosage and administration

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

Storage and handling

this rinse is not intended to replace brushing or flossing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.2%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

aids in the protection against oral infection.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-855-444-3556

SPL UNCLASSIFIED SECTION

Dist. by Hello Products
LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - 473 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55882-610255882-6102-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8f7653e7-d3f2-4c85-b160-0d1d7e9cc1a5a621e7e7-f139-4d90-b0c0-300ed958b5c12023-03-31WarningsExact identifier
spl id: 8f7653e7-d3f2-4c85-b160-0d1d7e9cc1a5
spl set id: a621e7e7-f139-4d90-b0c0-300ed958b5c1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.