FDA.reportPublic FDA data

Hello

Manufacturer
Hello Products LLC | Accupac
Effective date
2022-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:34:55

Label at a glance#

ProductHello
Active ingredientSODIUM FLUORIDE
Label structure10 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 a physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24% (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 a physician.

Inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, purified water, hydrated silica, glycerin, xylitol, xanthan gum, flavor, cocamidopropyl betaine, sodium cocoyl glutamate, stevia rebaudiana leaf extract, mica and titanium dioxide.

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 - 119 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

naturally
friendly™
hello®

unicorn sparkle
fluoride toothpaste
kids ages 2+

bubble gum
natural flavor

prevents cavities
polishes + brightens
strengthens enamel
tastes magical

never tested
on unicorns

no artificial sweeteners. no dyes.
no SLS/sulfates. no brainer.

NET WT 4.2 OZ (119g)

PRINCIPAL DISPLAY PANEL - 119 g Tube Box
PRINCIPAL DISPLAY PANEL - 119 g Tube Box

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55882-610755882-6107-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
MICAV8A1AW0880IACT

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
80a53212-e10e-44f7-b063-5ed4bca73858424cb024-3f21-45de-8ed1-81458759902f2022-01-19WarningsExact identifier
spl id: 80a53212-e10e-44f7-b063-5ed4bca73858
spl set id: 424cb024-3f21-45de-8ed1-81458759902f

Reported adverse events (FAERS/openFDA)#

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