Hello

Manufacturer
Hello Products LLC
Effective date
2023-03-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:33:47

Label at a glance#

ProductHello
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

Adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of us...

Storage and handling

store at room temperature do not use if printed band around cap is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05% (0.02% 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 rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:

  • use once a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • do not use if printed band around cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, vegetable glycerin, xylitol, sodium phosphate monobasic, flavor, poloxamer 407, phosphoric acid, potassium citrate.

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®

ADA
Accepted
American
Dental
Association ®

kids fluoride rinse
anticavity + no alcohol

wild strawberry
natural flavor

rinses away stuff brushing misses.

prevents cavities.

tastes awesome.

16 FL OZ (1 PT) 473 mL

44949

Principal Display Panel - 473 mL Bottle Label
Principal Display Panel - 473 mL Bottle Label

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55882-610355882-6103-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
c472b876-8689-47bb-a7b4-a8ebac81608c9d52eeaf-8811-4e00-a218-6ec90cae1da72023-07-01WarningsExact identifier
spl set id: 9d52eeaf-8811-4e00-a218-6ec90cae1da7

Reported adverse events (FAERS/openFDA)#

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