Hello

Manufacturer
Hello Products LLC | Accupac, Inc.
Effective date
2015-11-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:29:31

Label at a glance#

ProductHello
Active ingredientSodium fluoride
Label structure10 sections

Dosage and administration

Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or physician. Do not swallow. Children under 6 years of age: Use a pea-sized amount and supervise until good brushing habits are established to minimize swallowing. Children under 2 years of age: Consult 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

Aids in the prevention of dental 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.

Twist off cap to remove foil seal.

OTC - DO NOT USE SECTION

Do not use if safety seal is missing or broken.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or physician.
  • Do not swallow.
  • Children under 6 years of age: Use a pea-sized amount and supervise until good brushing habits are established to minimize swallowing.
  • Children under 2 years of age: Consult a dentist or a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Glycerin, Xylitol, Purified Water, Calcium Carbonate, Flavor, Xanthan Gum, Sodium Lauryl Sulfate, Titanium Dioxide 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 - 119 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

naturally
friendly
™
hello®

pure mint

extra whitening
fluoride toothpaste

whitens teeth
prevents cavities
strengthens enamel
freshens breath
feels awesome

no peroxide
no artificial sweeteners
no preservatives

NET WT 4.2OZ (119g)

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55882-6096-12023-03-10C16284748780-19d75b9d1-03ae-f424-e053-dadaa90a57ceHello ®
55882-6096-12020-01-31C16284748780-19d75b9d1-03ae-f424-e053-dadaa90a57ceHello ®

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55882-609655882-6096-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

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
fa9db25f-f5ab-4bf3-9e18-edc450b7c012cd63e88b-0ed5-46fe-a4c0-f99e28f1acd02015-11-23WarningsExact identifier
spl set id: cd63e88b-0ed5-46fe-a4c0-f99e28f1acd0

Reported adverse events (FAERS/openFDA)#

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