Hello

Manufacturer
Hello Products LLC
Effective date
2022-02-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:34:03

Label at a glance#

ProductHello Naturally Whitening
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure11 sections

Dosage and administration

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years: ask a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
  • children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
  • children under 2 years: ask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, purified water, hydrated silica, glycerin, xylitol, charcoal powder, flavor, xanthan gum, titanium dioxide, coconut oil, cocamidopropyl betaine, sodium cocoyl glutamate and stevia rebaudiana leaf extract

Questions?

OTC - QUESTIONS SECTION

855-HI-HELLO (1-855-444-3556)

SPL UNCLASSIFIED SECTION

Distributed by Hello Products LLC Montclair, NJ 07042

PRINCIPAL DISPLAY PANEL - 133 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hello®

naturally
whitening*
fluoride toothpaste

farm grown mint
with tea tree + coconut oil

NET WT4.7 OZ (133g)

Principal Display Panel - 133 g Tube Label
Principal Display Panel - 133 g Tube Label

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

hello®

activated charcoal
with fresh mint + coconut oil

epic whitening
fluoride toothpaste

NET WT 4.0 OZ (113g)

Principal Display Panel - 113 g Tube Label
Principal Display Panel - 113 g Tube Label

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55882-610055882-6100-1, 55882-6100-2
55882-610155882-6101-1, 55882-6101-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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
eeae6d56-7360-4a60-9f7d-f2f7fb1598c9d8ccd386-1294-4c85-9187-4efd6db47baf2022-02-08WarningsExact identifier
spl id: eeae6d56-7360-4a60-9f7d-f2f7fb1598c9
spl set id: d8ccd386-1294-4c85-9187-4efd6db47baf

Reported adverse events (FAERS/openFDA)#

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